Shionogi and F2G have reported positive top line data from the global OASIS Phase III study evaluating oral antifungal drug olorofim, compared with AmBisome followed by standard of care (SOC) in adults with invasive aspergillosis whose infection is refractory to or unsuitable for azole therapy.
The randomised, global study achieved its primary endpoint, demonstrating non-inferiority for olorofim with an all-cause mortality (ACM) rate of 23.8% at day 42.
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The ACM rate of AmBisome followed by SOC was 24.3%, representing a difference of -0.5% with a 95% confidence interval from -13.1% to 10.8%. No new safety concerns emerged.
Drug-related treatment-emergent adverse events were 35.8% for olorofim, compared to 63.9% for AmBisome and SOC, with the higher rate mainly due to more renal events in the AmBisome arm.
Previous Phase IIb data had led to breakthrough therapy designations from the US Food and Drug Administration for olorofim.
Shionogi and F2G plan to present full results at an upcoming medical congress, with the latter submitting the data to regulatory authorities in the US and Shionogi in Europe and Asia.
Shionogi board director John Keller said: “This is a promising new development in antifungal medicine — an area where patients have been underserved 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.”
Invasive aspergillosis mainly affects immunocompromised patients and carries high morbidity and mortality. Treatment choices remain limited, particularly for those unable to receive or who are unresponsive to azole-based therapies.
Shionogi and F2G are jointly developing and commercialising olorofim for invasive fungal infections. F2G will oversee commercial activity in North America and other designated markets, with Shionogi taking responsibility in Europe and Asia.
In March 2026, Shionogi enrolled the first patients in its global Phase II clinical trial, Esprit, assessing the investigational drug S-606001 in adults with late-onset Pompe disease.
