MANCHESTER, United Kingdom, Oct. 06, 2026 (GLOBE NEWSWIRE) -- F2G Ltd. today announced abstracts accepted for oral and poster presentation at IDWeek 2026, taking place October 21–24, 2026, at the Walter E. Washington Convention Center in Washington, D.C.
The Global Phase 3 OASIS data have been accepted for late-breaking oral abstract presentation building on the positive topline results announced in June. The oral presentation will be accompanied by poster presentations highlighting long-term follow-up data and health-related quality-of-life outcomes in patients with invasive fungal infections who have limited or no treatment options following treatment with olorofim. The OASIS study was a collaboration between F2G and Shionogi & Co.Ltd.
Details of the IDWeek 2026 presentations include:
Session: Late Breaking Abstracts: Antimicrobials
- Session Type: Oral Abstract
- Presentation: (LB-2201.2) Olorofim versus AmBisome®-Based Standard of Care (SOC) for Treatment of Invasive Aspergillosis (IA) in Patients for Whom a Mold-Active Azole Antifungal (MAA) is Inappropriate or Ineffective (OASIS): A Phase 3, Randomized, Controlled, Adjudicator-Blinded Non-Inferiority (NI) Trial (NCT05101187).
- Presenter: John H. Rex, MD, Chief Medical Officer, F2G
- Date and Time: Thursday, October 22, 2026, 10:30 AM – 11:45 AM ET
- Location: Room 206
Poster Session: Novel Agents (Poster P-4)
- Poster: Long-Term Follow-Up of Study 32 (S32LTFU): A Retrospective Observational Study to Collect Long-Term Follow-Up Data from Patients in Study 32, an Open-Label Single-Arm Phase IIb Study of Olorofim as Treatment of Invasive Fungal Infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options (NCT03583164).
- Presenter: George R. Thompson, MD, Professor of Medicine at the University of California, Davis, School of Medicine
- Date and Time: Thursday, October 22, 2026, 12:15 PM – 1:30 PM ET
- Location: Poster Hall B-C
Poster Session: Medical Mycology
- Poster: Health-Related Quality of Life in Patients with Invasive Fungal Infections with Limited or No Treatment Options: An Analysis of the Phase 2b Olorofim Trial Data.
- Presenter: Belinda Lovelace, PharmD, MS, MJ, Executive Director, Health Economics and Outcomes Research, F2G
- Date and Time: Saturday, October 24, 2026, 12:15 PM – 1:30 PM ET
- Location: Poster Hall B-C
About the Phase 3 OASIS Study
The Phase 3 OASIS (Olorofim Aspergillus Infection Study) trial (NCT05101187) was a global, randomized study that evaluated the efficacy and safety of olorofim versus AmBisome® 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’s primary endpoint was all-cause mortality at Day 42, with additional measures of clinical response, safety, and quality of life.
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 ≥ 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 (NCT03583164). These data enable continued clinical development and support future regulatory and commercial planning.
About Olorofim
Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and has been studied in a recently completed global Phase 3 trial (“OASIS”, NCT05101187). 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 F2G
F2G 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. F2G 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
F2G Media Contact:
Luke Shiplo
LifeSci Communications
F2GMedia@lifescicomms.com
AmBisome® is a registered trademark of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.
References:
- Vanbiervliet, Y., Van Nieuwenhuyse, T., Aerts, R. et al. Review of the novel antifungal drug olorofim (F901318). BMC Infect Dis 24, 1256 (2024). https://doi.org/10.1186/s12879-024-10143-3
- 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), 12809–12814. https://doi.org/10.1073/pnas.1608304113
- 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)
- Centers for Disease Control and Prevention. Data and statistics on aspergillosis. https://www.cdc.gov/aspergillosis/statistics/index.html (Accessed June 2026)
- US Food & Drug Administration. Orphan drug designations and approvals for olorofim. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm (Accessed June 2026)
