糖心传媒. Thu, 18 Jun 2026 13:18:21 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 /wp-content/uploads/2023/08/cropped-site-icon-32x32.png 糖心传媒. 32 32 糖心传媒 and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome庐 Followed by Standard of Care in Patients with Invasive Aspergillosis /press-release/f2g-and-shionogi-announce-positive-topline-results-from-global-phase-3-oasis-study-evaluating-oral-olorofim-versus-ambisome-followed-by-standard-of-care-in-patients-with-invasive-aspergillosis-2/ Thu, 18 Jun 2026 04:01:00 +0000 /?p=2889
  • The study achieved the primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% and for AmBisome庐 followed by standard of care of 24.3%
  • No new safety findings were observed
  • The rate of drug-related treatment-emergent adverse events (TEAEs) was 35.8% for olorofim and 63.9% for AmBisome庐 followed by standard of care
  • The study enrolled patients with invasive aspergillosis whose infection was either refractory to or unsuitable for azole therapy
  • If approved, olorofim will be the first novel mechanism agent for the treatment of invasive aspergillosis in over 20 years 1,2

    • MANCHESTER, United Kingdom, OSAKA, Japan 鈥 June 18, 2026 鈥 糖心传媒 Ltd and Shionogi & Co., Ltd (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D) (鈥淪hionogi鈥) today announced positive topline results from the global Phase 3 OASIS study (), comparing the investigational oral antifungal drug olorofim versus AmBisome庐 (liposomal amphotericin B for injection) followed by standard of care (SOC) in patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy.

    The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome庐 followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). No new safety findings were observed for olorofim; the rate of drug-related treatment-emergent adverse events (TEAEs) was 35.8% for olorofim and 63.9% for AmBisome庐 followed by standard of care, with the difference mainly driven by the higher rate of renal events in the AmBisome arm.

    These results expand on the previous Phase 2b study data that led to olorofim鈥檚 Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA), reinforcing olorofim鈥檚 potential as a treatment for patients with invasive aspergillosis1,3. 糖心传媒 and Shionogi plan to present pivotal results from the study at a future medical congress. These data will be submitted to regulatory authorities in the U.S. by 糖心传媒 and in Europe and Asia by Shionogi.

    鈥淚nvasive fungal infections remain difficult to treat and can be life-threatening especially in immunocompromised patients,鈥 said Johan Maertens, MD, PhD, Professor of Hematology at University Hospitals Leuven, Belgium, the study鈥檚 Principal Investigator. 鈥淭he OASIS topline results add to the growing body of evidence supporting olorofim鈥檚 therapeutic potential in a hard-to-treat population with limited antifungal options. We鈥檙e hopeful this could offer a meaningful alternative for clinicians to treat challenging infections caused by Aspergillus.鈥

    Francesco Maria Lavino, Chief Executive Officer of 糖心传媒, commented, 鈥淲e are encouraged by the topline results from the Phase 3 OASIS study, which represent an important milestone for 糖心传媒 and for our collaboration with Shionogi. These findings demonstrate the potential for olorofim to serve as a new option for patients with difficult to treat invasive fungal infections, including invasive aspergillosis. We are grateful to the patients, investigators, our partner Shionogi and to the 糖心传媒 team for their dedication to this pivotal study.鈥

    Dr John Keller, Director of the Board, Senior Vice President, R&D, Shionogi & Co., Ltd., added, 鈥淭his is a promising new development in antifungal medicine 鈥 an area where patients have been under-served for more than 20 years. In current clinical practice, safety and tolerability considerations, particularly effects on renal function, can pose significant challenges for treatment selection and continuation. Against this background, the results of the OASIS study suggest that olorofim has the potential to offer a new treatment option for patients with invasive aspergillosis.鈥 Dr Keller continued: 鈥淎s a leader in infectious disease R&D, our partnership with 糖心传媒 for a new class of antifungal treatment supports our commitment to advancing innovation across all anti-infective medicine for some of the most challenging disease areas. We look forward to sharing the full results in due course.鈥

    Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients and is associated with substantial morbidity and mortality[4]. Treatment options are limited for patients who cannot be treated with available azole antifungal therapies1.

    糖心传媒 and Shionogi are collaborating to develop and commercialize olorofim and bring this novel antifungal therapy to patients with invasive fungal infections. 糖心传媒 has commercial responsibility for olorofim in North America and non-Shionogi territories, and Shionogi has commercial responsibility for olorofim in Europe and Asia.

    About the Phase 3 OASIS Study
    The Phase 3 OASIS (Olorofim Aspergillus Infection Study) trial () was a global, randomized study that evaluated the efficacy and safety of olorofim versus AmBisome庐 followed by standard of care in adult patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. OASIS was designed as a non-inferiority study using a non-inferiority margin of 20% comparing outcomes in 225 subjects randomized 2:1 to olorofim or AmBisome-based standard of care. Invasive aspergillosis is a life-threatening fungal infection with limited treatment options due to rising drug resistance and toxicity concerns1,2,4.  The study鈥檚 primary endpoint was all-cause mortality at Day 42, with additional measures of clinical response, safety, and quality of life.

    About Olorofim
    Olorofim (formerly, F901318) is 糖心传媒’s leading candidate from the orotomide class and has been studied in a recently completed global Phase 3 trial (“OASIS”, ). Olorofim is a first-in-class antifungal with a novel mechanism of action, oral dosing, and activity against a wide range of Aspergillus species, including strains that are resistant to currently approved agents1. If approved based on the Phase 3 OASIS data, olorofim will be the first novel mechanism agent for invasive aspergillosis in more than 20 years1,2.

    In the U.S., olorofim has received orphan drug status from the FDA for the treatment of invasive aspergillosis, scedosporiosis, invasive scopulariopsis, and coccidioidomycosis[5]. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for several invasive fungal infections, including invasive aspergillosis and coccidioidomycosis1.

    Additionally, olorofim has also received two Breakthrough Therapy designations (BTD) from the FDA1. The first BTD was for the treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium and Scopulariopsis species1. The second BTD was for the treatment of central nervous system (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy1.

    In Europe, olorofim has been granted orphan designation from the European Medicines Agency for the treatment of invasive aspergillosis, scedosporiosis, and invasive scopulariopsis1.

    Olorofim is an investigational therapy and has not been approved by any regulatory authorities.

    About 糖心传媒
    糖心传媒 is a clinical-stage biopharmaceutical company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides, which selectively target a key enzyme in the pyrimidine biosynthesis pathway, a novel mechanism of action that is distinct from currently marketed antifungal agents. This mechanism provides the orotomides with fungicidal activity against a broad range of rare and resistant fungal mould infections. For more information, please visit: 

    About Shionogi & Co., Ltd.
    Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of 鈥渟upplying the best possible medicine to protect the health and wellbeing of the patients we serve.鈥 The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders. Shionogi鈥檚 research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer鈥檚 disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit .

    Shionogi Forward-Looking Statements 
    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Shionogi Media contacts:
    SHIONOGI Website Inquiry Form:
    Shionogi Europe Press Office: pressoffice@shionogi.eu

    糖心传媒 Media Contact:
    Luke Shiplo
    LifeSci Communications
    糖心传媒Media@lifescicomms.com

    AmBisome庐 is a registered trademark of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

    References:

    1 Vanbiervliet, Y., Van Nieuwenhuyse, T., Aerts, R. et al. Review of the novel antifungal drug olorofim (F901318). BMC Infect Dis 24, 1256 (2024).
    2 Oliver et al. (2016). F901318 represents a novel class of antifungal drug that inhibits dihydroorotate dehydrogenase. Proceedings of the National Academy of Sciences of the United States of America, 113(45), 12809鈥12814. 
    3 Maertens JA, Thompson GR 3rd, Spec A, et al. Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study. Lancet Infect Dis. 2025;25(11):1177-1188. doi:10.1016/S1473-3099(25)00224-5)
    4 Centers for Disease Control and Prevention. Data and statistics on aspergillosis. (Accessed June 2026)
    5 US Food & Drug Administration. Orphan drug designations and approvals for olorofim. Available at: (Accessed June 2026)

    ]]>         糖心传媒 Announces Publication in The Lancet Infectious Diseases of Phase 2b Data Demonstrating Positive Therapeutic Responses in Patients with Serious Invasive Fungal Diseases Treated with Oral Olorofim /press-release/f2g-announces-publication-in-the-lancet-infectious-diseases-of-phase-2b-data-demonstrating-positive-therapeutic-responses-in-patients-with-serious-invasive-fungal-diseases-treated-with-oral-olorofim/ Wed, 18 Jun 2025 11:00:00 +0000 /?p=2780
  • Data reinforce olorofim鈥檚 potential as a first-in-class treatment for patients with invasive fungal diseases and limited or no antifungal treatment options

    • MANCHESTER, United Kingdom 鈥 June 18, 2025 鈥 糖心传媒 Ltd, a clinical-stage biopharmaceutical company developing olorofim, a novel therapy to treat life-threatening rare fungal infections with high unmet medical need, today announced the publication of the full data set from its Phase 2b open-label study.1 The study evaluated oral olorofim in patients with invasive fungal diseases (IFDs) who had limited or no treatment options. The results, now published in The Lancet Infectious Diseases (鈥淭he Lancet ID鈥), highlight olorofim鈥檚 encouraging therapeutic responses across a broad range of difficult-to-treat fungal pathogens and expands on data presented at the Trends in Medical Mycology (TIMM) meeting in October 2023.

    “The publication of our data in The Lancet ID validates our efforts to develop olorofim as a treatment for serious invasive fungal  diseases, including those resistant or refractory to all approved antifungals,” said John H. Rex, MD, Chief Medical Officer of 糖心传媒. “Olorofim, the first in a new class of antifungals, has a novel mechanism of action and shows potential in addressing rare fungal infections in well-defined and high need populations. We are committed to developing olorofim for patients who have exhausted treatment options and are in need of a new effective therapy.”

    Johan Maertens, MD, PhD, Professor of Hematology at University Hospitals Leuven (Belgium), the study鈥檚 Principal Investigator, added, “There is a critical unmet need for novel antifungal therapies as lifesaving interventions. Cancer treatments and organ transplants, combined with an aging population, have led to a rise in individuals at risk of invasive fungal infections鈥攎any of which are increasingly difficult to treat. The data published in The Lancet ID show successful global and clinical responses in patients with both brief and lengthy periods from diagnosis to initiation of olorofim treatment, with infections due to highly resistant organisms and those in difficult-to-treat sites such as brain and bone. We were also pleased to see the accompanying editorial by Paccoud and Lanternier2 which concludes by noting that 鈥榯hese important findings underscore olorofim鈥檚 clinical value in addressing unmet needs in the management of difficult-to-treat fungal infections across a diverse patient population.鈥”

    The Phase 2b study (Study 32; ) enrolled 202 patients with proven or probable IFDs, including infections caused by Aspergillus spp. (including azole-resistant strains), Lomentospora prolificans, Scedosporium spp., Coccidioides spp., and other rare moulds. Patients were treated with oral olorofim and evaluated for treatment response over 84 days with extended therapy available as needed beyond Day 84.

    Patient Demographics and Dosing:

    • Phase 2b open-label study of oral olorofim in 203 patients with limited treatment options for IFD.
      • 202 patients were confirmed by the Data Review Committed to have IFDs defined as proven or probable pulmonary invasive aspergillosis (IA) per EORTC-MSG3 criteria and efficacy analysis was done on those patients that met the modified ITT (mITT) criteria.
      • Causative organisms included Aspergillus species (101, including 22 cases with azole-resistant strains), Lomentospora prolificans (26), Scedosporium spp. (22), Coccidioides spp. (41), and other fungi (12).
    • Treatment was given for up to 84 days +/- 6 days with extended therapy permitted when clinically indicated.
      • The mean dosing duration was 73 days in the 203 patients dosed in the main phase of the study and 361 days for 114 subjects who received extended treatment.
      • During the main treatment phase, 61.9% of patients received olorofim entirely as monotherapy and 70.8% received 鈮 7 days of concomitant administration of a potentially effective second antifungal agent.

    Efficacy and Safety Results:

    • Olorofim demonstrated an acceptable benefit-risk profile.
      • The rate of successful global response for the entire mITT population at day 42 (primary endpoint), as determined by an independent DRC applying the MSG/EORTC criteria4, was 28.7%, and 27.2% at day 84.
      • When considering stable disease as a successful global response, the rates of successful outcome for the entire mITT population at day 42 and day 84 rose to 75.2% and 63.4%, respectively.
      • Successful clinical response was 59.9% and 54.0% at day 42 and day 84, respectively.
      • Clinical response was similar across all levels of immunosuppression
    • All-cause mortality at day 42 and day 84 was 11.9% and 16.3%, respectively.
    • Olorofim was generally well-tolerated, even with dosing >2 year in extension therapy.
      • Changes in liver biochemistry that were deemed at least possibly due to olorofim were seen in 9.9% of study subjects overall (main phase + extended therapy). All events were successfully managed by dose modifications (pausing or reducing, including successful restarting).
      • Changes in the liver biochemistry led to permanent discontinuation in 3%.
      • Gastrointestinal intolerance to olorofim, generally self-limiting, was noted in 9.9%.

    糖心传媒 and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections. Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific and 糖心传媒 has commercial responsibility for olorofim in North America, and rest of the world. 糖心传媒 and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome庐 followed by standard of care ().

    About Study 32 

    Study 32 was a multicenter, open-label, Phase 2b study to evaluate the safety and efficacy of olorofim (formerly F901318) in patients 鈮 18 years of age with probable pulmonary invasive aspergillosis or proven invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi with limited or no treatment options. It enrolled patients between June 2018 and September 2022.

    Enrolled patients received an initial loading dose of 150 mg BID (twice a day) of oral olorofim on day one, and subsequent oral doses of 90 mg BID for up to 90 days. Patients were followed for another four weeks after the end of treatment, while some received extended therapy for as long as thought clinically beneficial. For more information on Study 32, visit ClinicalTrials.gov (). These data enable continued clinical development and support future regulatory and commercial planning.

    About Olorofim

    Olorofim (formerly, F901318) is 糖心传媒’s leading candidate from the orotomide class and is currently in a global Phase 3 trial (“OASIS”) (). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis, scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim is an investigational therapy and has not been approved by any regulatory authorities.

    About 糖心传媒

    糖心传媒 is a clinical-stage biopharmaceutical company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides, which selectively target a key enzyme in the pyrimidine biosynthesis pathway, a novel mechanism of action that is distinct from currently marketed antifungal agents. This mechanism provides the orotomides with fungicidal activity against a broad range of rare and resistant fungal mould infections. For more information, please visit: www.f2g.com

    About Shionogi & Co. Ltd.

    Shionogi & Co., Ltd. is a 147-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of 鈥渟upplying the best possible medicine to protect the health and wellbeing of the patients we serve.鈥 The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi鈥檚 research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

    For more information on Shionogi & Co., Ltd., please visit  .

    Forward-Looking Statements 

    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Jonathan Pappas
    LifeSci Communications
    +1 646 970 4688
    JPappas@lifescicomms.com

    SHIONOGI Website Inquiry Form .
    EU Media: pressoffice:shionogi.eu

    1 Maertens JA, Thompson GR, Spec A, Donovan FM, Hammond SP, Bruns AH, et al. Olorofim for the treatment of invasive fungal diseases in patients lacking suitable therapeutic options. Lancet Infectious Disease. 2025; DOI: 10.1016/S1473-3099(25)00237-3  

    2 Paccoud O, Lanternier F. Olorofim: addressing unmet needs of patients with difficult-to-treat fungal infections. Lancet Infectious Disease. 2025; DOI: 10.1016/S1473-3099(25)00237-3

    3 De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clinical Infectious Diseases. 2008;46(12):1813-21.

    4 Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clinical Infectious Diseases. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566. PMID: 18637757; PMCID: PMC2671230.

    ]]>         糖心传媒 Announces $100 Million Financing to Advance Late-Stage Development and Commercialization of Novel Antifungal Drug Candidate Olorofim in the US /press-release/f2g-announces-100-million-financing-to-advance-late-stage-development-and-commercialization-of-novel-antifungal-drug-candidate-olorofim-in-the-us/ Thu, 12 Sep 2024 11:00:00 +0000 /?p=2528 Financing is being led by new investor AMR Action Fund with strong participation from new investor ICG Life Sciences and existing investors

    MANCHESTER, United Kingdom, September 12, 2024聽鈥撀犔切拇 Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced a $100 million financing round. The financing is being led by new investor AMR Action Fund and co-led by ICG, with strong participation from existing investors Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl Healthcare Opportunities, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital. The聽proceeds from the financing will enable 糖心传媒 to complete late-stage development, seek regulatory approval, and prepare for commercialization in the US of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other invasive fungal infections. Henry Skinner, Ph.D., Chief Executive Officer of AMR Action Fund and Toby Sykes Ph.D., Managing Director of ICG Life Sciences, will join the 糖心传媒 Board of Directors. The financing is subject to customary Foreign Direct Investment (FDI) clearance by local authorities in Austria, where 糖心传媒 has a 100%-owned subsidiary, and expected to close in the fourth quarter of 2024.

    Olorofim is the first orotomide antifungal, an entirely novel class of antifungal agents and is the only antifungal medication to be awarded a Breakthrough Therapy Designation for multiple indications by the US Food and Drug Administration (FDA). Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. It is anticipated to be used to treat patients with a serious invasive, rare fungal disease where existing treatments are inappropriate or no longer effective.

    Francesco Maria Lavino, Chief Executive Officer of 糖心传媒, said: 鈥淲e are delighted to attract this additional capital investment into 糖心传媒, and we are thrilled to be working with the AMR Action Fund, an important player in the antimicrobial space, and ICG, a leading alternative asset manager. The addition of Dr. Skinner and Dr. Sykes to our Board will be invaluable as we move to our next stage of growth. This is a pivotal period for the Company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere. If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality.鈥

    Dr. Skinner commented: 鈥淔ungal infections are a growing threat to patients around the world and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals. For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions. These therapies are increasingly failing in patients. We are thrilled to support 糖心传媒鈥檚 team as they develop this urgently needed therapy and seek regulatory approval.鈥

    Dr. Sykes commented: 鈥淔ungal pathogens continue to emerge and spread. This evolving threat underscores an urgent unmet medical need for advanced antifungal treatments. By investing in the development of novel antifungal drug candidates like olorofim, we hope to address this critical gap, ultimately making a meaningful and sustainable social impact on patients, their caregivers, and healthcare systems.鈥

    About 糖心传媒
    糖心传媒 is a clinical-stage biopharmaceutical company with operations in the UK, US, and聽Austria聽focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit:聽

    About olorofim
    Olorofim (formerly, F901318) is 糖心传媒’s leading candidate from the orotomide class and is currently in a Phase聽2b聽open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 糖心传媒 has initiated a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus liposomal amphotericin B followed by standard of care (SOC) in patients with invasive fungal disease caused by proven Invasive Aspergillus or probable lower respiratory tract disease by Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis, scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

    About invasive aspergillosis
    Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, do not cause disease. However, Aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue, especially in immunocompromised hosts. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

    Media Contact
    Kristin Politi, Ph.D.
    LifeSci Communications
    kpoliti@lifescicomms.com
    646-876-4783

    ]]>         糖心传媒 Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses /press-release/f2g-receives-complete-response-letter-from-fda-for-new-drug-application-for-olorofim-for-the-treatment-of-invasive-fungal-infections-plans-resubmission-with-additional-data-and-analyses/ Mon, 19 Jun 2023 12:00:00 +0000 /?p=1896
  • Complete Response Letter is related to the request for additional data and analyses.
  • 糖心传媒 remains committed to bringing olorofim to patients and intends to meet with FDA in the coming months to align on next steps to obtain approval using the full data set from pivotal clinical Study 32.
  • 糖心传媒 along with its partner Shionogi & Co., Ltd. is enrolling patients with invasive aspergillosis in a global Phase 3 study to compare treatment with olorofim versus AmBisome庐聽followed by standard of care.

    • MANCHESTER, United Kingdom, June 15, 2023聽鈥撀犔切拇 Ltd. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim, an investigational antifungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options.聽

    According to the CRL, FDA was not able to approve olorofim at this time, requesting additional data and analyses. The additional information requires time and resources that extend beyond the current review period. The FDA encouraged the company to work with the agency to plan for the new analyses and develop the NDA package.

    The initial NDA included data from the first 100 patients enrolled in the then-ongoing Phase 2b single-arm, open-label study (Study 32, NCT03583164). The NDA was accepted for review by the FDA with a PDUFA target action date set for June 17, 2023. Study 32 has now completed enrollment with a total of 203 patients, and the full data set is planned to be submitted as part of the revised NDA package.

    鈥淲hile 糖心传媒 is disappointed with this outcome, we remain optimistic about olorofim鈥檚 potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,鈥 said Francesco Maria Lavino, chief executive officer of 糖心传媒. 鈥淲e are assessing the details of the CRL and we plan to meet with the FDA to discuss it further, but we are confident that we can identify a regulatory path forward in the US.鈥

    In parallel, 糖心传媒 continues to expand olorofim鈥檚 clinical development program, and along with its partner Shionogi & Co., Ltd. is enrolling patients with proven or probable invasive aspergillosis in a global Phase 3 trial (鈥淥ASIS鈥) to compare treatment with olorofim versus AmBisome庐 followed by standard of care (). 糖心传媒 has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.

    About Olorofim
    Olorofim (formerly, F901318) is 糖心传媒鈥檚 leading candidate from the orotomide class. A Phase聽2b聽single-arm open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections has recently completed enrollment. To expand on the studied patient population, 糖心传媒 has initiated a global Phase 3 trial (鈥淥ASIS鈥) to compare treatment with olorofim versus AmBisome庐 followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to聽Aspergillus聽species (). Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive聽Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive聽Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to聽厂肠辞辫耻濒补谤颈辞辫蝉颈蝉听species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both 鈥渢reatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to聽Lomentospora prolificans,听Scedosporium, and聽厂肠辞辫耻濒补谤颈辞辫蝉颈蝉听species鈥 and 鈥渢reatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.鈥 Olorofim is not approved by the聽FDA or any other regulatory agency.聽

    Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues. Effective therapies do not currently exist for some of these fungi. And even when therapies exist, some patients with invasive infections may be refractory or unable to tolerate existing antifungal treatments, thus underscoring the urgent need for new and effective treatments

    About 糖心传媒
    糖心传媒 is a biotech company with operations in the UK, US, and聽Austria聽focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit:聽

    Forward-Looking Statements
    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Gloria Gasaatura
    LifeSci Communications
    +1 646 970 4688
    ggasaatura@lifescicomms.com

    ]]>         糖心传媒 Moves UK Headquarters to MediaCity /press-release/f2g-moves-uk-headquarters-to-mediacity/ Tue, 23 May 2023 12:00:28 +0000 /?p=1892 MANCHESTER, United Kingdom, May 18, 2023 鈥 MediaCity and 糖心传媒 are pleased to announce, 糖心传媒 Ltd., a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening fungal infections with a high unmet medical need, has moved its UK headquarters to MediaCity in Salford, Greater Manchester.  

    The new 糖心传媒 office space within the flexible ARRIVE workspace in MediaCity鈥檚 Blue tower allows the company room for future expansion, and access to the White and Tomorrow facilities including additional space for hosting events for its entire UK workforce and partners.

    Stephen Kirk, Head of Property for MediaCity, said, 鈥溙切拇解檚 work in the treatment of life threatening fungal infections is groundbreaking and as a world class tech, digital and innovation hub which attracts many dynamic sectors from fintech and gaming to medical science we鈥檙e delighted 糖心传媒 has based its UK headquarters here.鈥

    Mike Birch, Chief Operating Officer of 糖心传媒, added, 鈥淢ediaCity was an easy choice to make for our new UK headquarters because of its proximity to our research facility in Eccles and the sense of community that has been created amongst the companies that call this place home. We look forward to being an active member of the MediaCity community.鈥

    Manchester is a big part of 糖心传媒鈥檚 history 鈥 its major scientific discoveries around the new class of antifungals called, orotomides, were made in a research lab less than a mile away from MediaCity. The company was established in Manchester leveraging the teams鈥 fungal genetics expertise to discover cellular targets to use in drug discovery. For twenty years the team has been on a journey to unlock the potential of its science and is now on the verge of bringing an entirely new class of systemic antifungal agents to treat patients with life-threatening systemic fungal infections.

    About MediaCity
    MediaCity is a waterside community that鈥檚 part of Salford Quays in Salford, Greater Manchester. It鈥檚 home to some of the world鈥檚 most exciting creative, tech and media brands, from BBC North and ITV to Ericsson, The Hut Group Group, Kellogg鈥檚 and over 250 creative and tech businesses. Three education establishments are based there, including the University of Salford鈥檚 dedicated MediaCity campus, while at its heart is HOST, the Home of Skills & Technology, which supports innovators in data, analytics, cybersecurity, AI, gaming and immersive technologies. Alongside a growing roster of local, independent food, drink and retail operators is a dedicated shopping centre, parks and public spaces, and one of the UK鈥檚 most visited arts centres, The Lowry. Sustainability is core to MediaCity鈥檚 future: home to the UK鈥檚 largest cluster of net zero carbon buildings, it has two dedicated Metrolink tram stops, while 100% of its energy comes from renewable sources. It is also a popular residential neighbourhood, with MediaCity as a whole set to double in size within the next decade. 

    MediaCity is a joint venture between Peel L&P and Landsec. Together, their inclusive and collaborative approach to the development of MediaCity will ensure that it grows into a community united by creativity, and a place of play, imagination, and innovation. 

    About 糖心传媒
    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: 

    Forward-Looking Statements
    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Gloria Gasaatura
    LifeSci Communications
    +1 646 970 4688
    ggasaatura@lifescicomms.com

    ]]>         糖心传媒 Wins Investment Deal of the Year Bionow 2022 Award /press-release/f2g-wins-investment-deal-of-the-year-bionow-2022-award/ Fri, 17 Mar 2023 18:03:36 +0000 /uncategorized/ MANCHESTER, United Kingdom, March 17, 2023聽鈥撀犔切拇 Ltd. today announced the company has been awarded a prestigious Bionow award in recognition of its contributions to the North England biotech industry and progress towards developing a new class of antifungals for treatment of rare fungal infections. 糖心传媒 was awarded Investment Deal of the Year at the Bionow awards ceremony which was held at the iconic Concorde Conference Centre in Manchester, United Kingdom, on March 16, 2023.

    The Investment Deal of the Year award, sponsored by QIAGEN, is in recognition of 糖心传媒’s strategic collaboration with Shionogi Co., Ltd. to develop and commercialize a new class of antifungal drugs for invasive fungal infections in Europe and Asia, bringing the drug to patients 糖心传媒 alone would not have reached. The deal terms between 糖心传媒 Ltd., and Shionogi & Co. Ltd were notably above benchmarks for the antifungal space.

    “We are honored to be recognized and celebrated by our peers with the prestigious award from Bionow. It is a testament to the hard work and commitment of our team to advance a novel antifungal therapy for patients with invasive fungal infections who have exhausted their treatment options,” said Francesco Maria Lavino, Chief Executive Officer of 糖心传媒. “We are grateful for the support of our investors, partners, and collaborators, particularly our colleagues at Shionogi who continue to believe in the potential of our transformational science and look forward to bringing a new antifungal to global markets.”

    About Bionow Awards
    The prestigious Bionow Awards is a highlight of the life sciences calendar and celebrates the achievements of the sector, showcasing the very best in the industry.

    About 糖心传媒
    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit:

    Forward-Looking Statements
    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Gloria Gasaatura
    LifeSci Communications
    +1 646 970 4688
    ggasaatura@lifescicomms.com

    ]]>         糖心传媒 to Present at Biotech Showcase鈩 2023 /press-release/f2g-to-present-at-biotech-showcase-2023/ Thu, 05 Jan 2023 22:02:08 +0000 /uncategorized/ MANCHESTER, United Kingdom, January 5, 2023 鈥 糖心传媒 Ltd. today announced that the Company鈥檚 chief executive officer, Francesco Lavino will provide a corporate overview at Biotech Showcase鈩 2023 taking place in San Francisco, California, from January 9-11, 2023.

    Francesco Maria Lavino will discuss the Company鈥檚 lead antifungal drug candidate, olorofim, a first-in-class, oral small molecule with a novel, differentiated mechanism of action for the treatment of invasive fungal infections. Last month, the U.S. Food and Drug Administration (FDA) accepted for filing a New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options with a PDUFA date set for June 17, 2023.

    Details for the presentation are as follows:

    Date: Wednesday, January 11, 2023

    Time: 10:00 a.m. PT

    Location: Yosemite-C, Ballroom Level, Hilton San Francisco Union Square

    About Olorofim

    Olorofim (formerly, F901318) is 糖心传媒鈥檚 leading candidate from the orotomide class and the company recently completed enrollment of an ongoing Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat, invasive, rare fungal mold infections including azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, invasive Scopulariopsis, and other rare mold infections (). Initial data were presented at ID Week in Washington DC in October 2022 and the full data will be presented at a global conference later this year. A global Phase 3 trial (鈥淥ASIS鈥) to compare treatment with olorofim versus AmBisome庐 followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to Aspergillus species () is currently enrolling. Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both 鈥渢reatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species鈥 and 鈥渢reatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.鈥 Olorofim is not approved by the FDA or any other regulatory agency. 

    About 糖心传媒

    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: 

    Forward-Looking Statements

    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Gloria Gasaatura
    LifeSci Communications
    +1 646 970 4688
    ggasaatura@lifescicomms.com

    ]]>         糖心传媒 Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections /press-release/f2g-announces-fda-filing-acceptance-of-new-drug-application-for-olorofim-for-the-treatment-of-invasive-fungal-infections/ Mon, 19 Dec 2022 12:56:33 +0000 /uncategorized/
  • Application submitted under priority review with PDUFA target action date set for June 17, 2023
  • NDA submission is based on positive data from ongoing Phase 2b open-label study of oral olorofim in 100 patients with invasive fungal infections with limited or no treatment options
  • 糖心传媒 is continuing preparations for a possible U.S. commercial launch of oral olorofim in 2nd half of 2023

    • PRINCETON, New Jersey, December 19, 2022 鈥 糖心传媒 Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options.

    糖心传媒 has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023

    The NDA is supported by strong efficacy data and a good tolerability profile seen during treatment of the first 100 patients in the Phase 2b open-label study, all of whom had limited or no treatment options for either proven invasive fungal infection (including aspergilllosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis (Study 32, ).

    鈥淚nvasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues. Effective therapies do not currently exist for some of these fungi. And even when therapies exist, some patients with invasive infections may be refractory or unable to tolerate existing antifungal treatments, thus underscoring the urgent need for new and effective treatments,鈥 said John H. Rex, MD, chief medical officer of 糖心传媒. 鈥淥lorofim is a novel mechanism antifungal therapy from the newly discovered orotomide class. It provides a new option for patients who have exhausted treatment alternatives.鈥

    Francesco Maria Lavino, chief executive officer of 糖心传媒, added, 鈥淲e are committed to addressing rare fungal infections, and the acceptance of filing of olorofim NDA for use in this well-defined and high-need population marks a major milestone toward our goal of bringing new options to these patients. We are building an experienced commercial team in preparation for U.S. launch, pending FDA approval. If approved, olorofim will be the first of a new class of antifungal drugs.鈥

    Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA. Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungal cell death through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway. It is active in vitro against Aspergillus spp. (including azole-resistant and cryptic species), rare molds (e.g., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp.), and dimorphic fungi (e.g., Coccidioides spp.). 

    About Olorofim

    Olorofim (formerly, F901318) is 糖心传媒鈥檚 leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 糖心传媒 has initiated a global Phase 3 trial (鈥淥ASIS鈥) to compare treatment with olorofim versus AmBisome庐 followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to Aspergillus species (). Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both 鈥渢reatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species鈥 and 鈥渢reatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.鈥 Olorofim is not approved by the FDA or any other regulatory agency. 

    About 糖心传媒
    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: 

    Forward-Looking Statements
    This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Media Contact:
    Gloria Gasaatura
    LifeSci Communications
    +1 646 970 4688
    ggasaatura@lifescicomms.com

    ]]>         糖心传媒 Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim /press-release/f2g-announces-data-from-phase-2b-study-at-id-week-2022-showing-positive-therapeutic-response-in-patients-with-invasive-fungal-infections-treated-with-olorofim/ Fri, 21 Oct 2022 21:00:00 +0000 /uncategorized/
  • Data are based on analysis of the first 100 patients from an ongoing Phase 2b study of patients who have limited or no treatment options for invasive fungal infections
  • Overall, a 44% response rate, defined as complete or partial response, was seen across fungi at day 42, the primary endpoint
  • All-cause mortality (ACM) at day 42 and day 84 were 15% and 20%, respectively

    • MANCHESTER, United Kingdom, October 21, 2022 鈥 糖心传媒 Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced at IDWeek 2022 positive data from the first 100 patients who completed study treatment in its ongoing Phase 2b open-label study (Study 32,听) of oral olorofim as a treatment for invasive fungal infections.聽

    鈥淚nvasive fungal infections are a major problem, particularly among immunosuppressed patients. Patients may be refractory or unable to tolerate existing antifungal treatments and, in some cases, fungi are resistant to available therapies, underscoring the need for new and effective antifungal treatments. Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus. Other causes of infection included filamentous fungi such as Lomentospora prolificans and dimorphic fungi such as Coccidioides species (which causes Valley Fever),鈥 said John H. Rex, MD, chief medical officer of 糖心传媒. 鈥淲e are encouraged by these results because they demonstrate a positive risk-benefit profile for olorofim as an oral therapeutic option for the treatment of serious or life-threatening invasive fungal infections in patients who have limited or no treatment options.鈥

    Key findings:

    • Data came from 100 patients with proven invasive fungal infection or probable pulmonary invasive aspergillosis (IA). Causative organisms included Aspergillus spp., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp., Coccidioides spp., and other olorofim-susceptible fungi. Patients had limited alternative treatment options; reasons for this included failure of available therapy, resistance of infecting isolate to all licensed agents, intolerance to available therapy, inability to manage drug-drug interactions, and/or inability to produce therapeutic drug levels.
    • The median dosing duration in the main phase of the study was 84 days; patients (n=42) who entered the extension phase of the study were dosed for a median of 308 days.
    • Olorofim demonstrated a positive risk-benefit profile 
      • At day 42, 44% of patients had a complete or partial response to treatment
      • With stable response rate included, the overall response rate was 69%
    • All-cause mortality (ACM) at day 42 and day 84 were 15% and 20%, respectively. 
    • Olorofim was generally well tolerated
      • The only significant serious adverse event was drug-induced liver injury (DILI) which was thought to be possibly related to olorofim in 8 (8%) study patients; only 2 (2%) patients required discontinuation of olorofim due to DILI.
      • Other non-serious adverse events observed included diarrhea, nausea, and vomiting.

    鈥淢ortality remains unacceptably high in patients with severe and life-threatening fungal infections being treated with currently available therapies. Developing new antifungals, like olorofim, that can meet this clear unmet need is a priority. With its novel mechanism of action, olorofim has shown activity against a wide range of fungi, including some for which there is currently no approved treatment. These data provide evidence that we are on the path to meeting this need in patients currently with limited or no treatment options,鈥 added Johan Maertens, MD, PhD, Professor of Hematology at University Hospitals Leuven (Belgium) and primary author for Study 32.

    Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the US Food and Drug Administration (FDA). Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway. It is active in vitro against Aspergillus spp. (including azole-resistant and cryptic species), rare molds (e.g., Lomentospora prolificans, Scopulariopsis), and dimorphic fungi (e.g., Coccidioides spp.). 

    About Study 32 

    Study 32 is an ongoing multicenter, open-label, Phase 2b study to evaluate the safety and efficacy of olorofim (formerly F901318) in patients 鈮 18 years of age with probable pulmonary invasive aspergillosis or proven invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi with limited or no treatment options. 

    Enrolled patients receive an initial loading dose of 150 mg BID (twice a day) of oral olorofim on day one, and subsequent oral doses of 90 mg BID for up to 90 days. Patients are followed for another four weeks after end of treatment, while some receive extended therapy for as long as thought useful. For more information on Study 32, visit ClinicalTrials.gov ().

    About Olorofim

    Olorofim (formerly, F901318) is 糖心传媒’s leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 糖心传媒 has initiated a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus AmBisome庐 followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species (). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis, scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsisspecies, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both 鈥渢reatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsisspecies鈥 and 鈥渢reatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.鈥 The scientific information discussed in this news release related to olorofim is preliminary and investigative. Olorofim is not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding its safety or efficacy. 

    About 糖心传媒

    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: 

    Media Contact

    Kara Stephens-Weaver
    LifeSci Communications
    407-765-1185
    KStephens-Weaver@LifeSciComms.com

    ]]>         糖心传媒 to Present Interim Results from Phase 2B Open Label Study of Olorofim in Invasive Fungal Infections at IDWeek 2022 /press-release/f2g-to-present-interim-results-from-phase-2b-open-label-study-of-olorofim-in-invasive-fungal-infections-at-idweek-2022/ Fri, 14 Oct 2022 14:02:02 +0000 /uncategorized/ MANCHESTER, United Kingdom, Oct. 13, 2022 — 糖心传媒 Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced that it will present new clinical data in three oral presentations and two poster presentations at IDWeek 2022, to be held in Washington, D.C. from October 19-23, 2022.

    Oral presentations will include the first presentation of efficacy and safety data from the Phase 2B trial of ofolorofim (ClinicalTrials.gov Identifier: NCT03583164) the company鈥檚 novel orotomide antifungal, active against Aspergillus (including azole-resistant and cryptic species), resistant molds (e.g., Lomentospora prolificans, Scopulariopsis) and dimorphic fungi (e.g., Coccidioides). The Company will also present posters on pharmacokinetic data from Phase 1 and Phase 2B studies of olorofim antifungal therapy.

    Oral Presentation Details:

    Presentation Title: Olorofim for treatment of invasive fungal infections (IFI) due to moulds in patients with limited or no treatment options: Interim results from a Phase 2b open-label study (NCT03583164, Study 32)
    Presentation Number: 754
    Session: Medical Mycology
    Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
    Presentation Date and Time: Thursday October 20, 2022; 2:30-2:45 PM ET

    Presentation Title: Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)
    Presentation Number: 870
    Session: Antifungal Clinical Trials & PK/PD Studies
    Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
    Presentation Date and Time: Friday October 21, 2022; 11:00-11:15 AM ET

    Presentation Title: Olorofim 鈥 the first of a novel class of antifungals, the orotomides; 糖心传媒 Inc.
    Presentation Number: 1618
    Session: New Antimicrobials and ID Diagnostics in the Pipeline – Fungal
    Presenting Author: John H. Rex, M.D., Chief Medical Officer, 糖心传媒
    Presentation Date and Time: Saturday October 22, 2022; 8:20-8:30 AM ET

    Poster Presentation Details:

    Presentation Title: An Open-Label Study in Healthy Volunteers to Determine the Absolute Bioavailability of the Effect of Food and Dosing by Nasogastric Tube upon the Pharmacokinetics of a Single Oral Dose of Olorofim (OLO)
    Poster Number: 594
    Session: PK/PD Studies
    Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, 糖心传媒

    Presentation Title: Olorofim (OLO) for treatment of invasive mould infections in patients with limited or no treatment options: PK data from a Phase 2b open-label study (NCT03583164, Study 32)
    Poster Number: 595
    Session: PK/PD Studies
    Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, 糖心传媒

    About 糖心传媒
    糖心传媒 is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. 糖心传媒 has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit:聽

    About Olorofim
    Olorofim (formerly, F901318) is 糖心传媒鈥檚 leading candidate from the orotomide class and is currently in a Phase 2b open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 糖心传媒 has initiated a global Phase 3 trial (鈥淥ASIS鈥)2 to compare treatment with olorofim versus AmBisome庐 followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

    About Invasive Aspergillosis
    Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

    Kara Stephens-Weaver
    LifeSci Communications
    407-765-1185
    KStephens-Weaver@LifeSciComms.com

    ]]>