F2G and Shionogi Report Positive Phase 3 Results for Oral Antifungal Olorofim in Invasive Aspergillosis
F2G and Shionogi have announced positive topline results from the global Phase 3 OASIS study of olorofim, an oral antifungal for invasive aspergillosis, demonstrating non‑inferior mortality versus AmBisome with fewer drug‑related adverse events.
The study met its primary endpoint, showing an all‑cause mortality rate of 23.8% for olorofim versus 24.3% for AmBisome followed by standard of care, with a key safety advantage as drug‑related treatment‑emergent adverse events were 35.8% for olorofim versus 63.9% for AmBisome.
If approved, olorofim would be the first novel mechanism antifungal agent for invasive aspergillosis in over 20 years, with F2G planning U.S. regulatory submissions and Shionogi targeting Europe and Asia.
Sources:
A Scientific Breakthrough in Antifungal Treatments - F2G
F2G, Shionogi share positive ph. 3 oral antifungal data - Fierce Biotech
[PDF] F2G Ltd - Access to Medicine Foundation
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