• 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® 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® 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

F2G Ltd and Shionogi & Co., Ltd (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D) (“Shionogi”)  announced positive topline results from the global Phase 3 OASIS study (NCT05101187), comparing the investigational oral antifungal drug olorofim versus AmBisome® (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® 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® 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’s Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA), reinforcing olorofim’s potential as a treatment for patients with invasive aspergillosis^1,3. F2G 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 F2G and in Europe and Asia by Shionogi.

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

Francesco Maria Lavino, Chief Executive Officer of F2G, commented, “We are encouraged by the topline results from the Phase 3 OASIS study, which represent an important milestone for F2G 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 F2G team for their dedication to this pivotal study.”

Dr John Keller, Director of the Board, Senior Vice President, R&D, Shionogi & Co., Ltd., added, “This is a promising new development in antifungal medicine – 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.” Dr Keller continued: “As a leader in infectious disease R&D, our partnership with F2G 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.”

Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients and is associated with substantial morbidity and mortality⁴. Treatment options are limited for patients who cannot be treated with available azole antifungal therapies¹.

F2G and Shionogi are collaborating to develop and commercialize olorofim and bring this novel antifungal therapy to patients with invasive fungal infections. F2G has commercial responsibility for olorofim in North America and non-Shionogi territories, and Shionogi has commercial responsibility for olorofim in Europe and Asia.