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

F2G and Shionogi announced positive results from the Phase 3 OASIS study of olorofim, an investigational oral antifungal drug for invasive aspergillosis. The study met its primary non-inferiority endpoint with all-cause mortality at Day 42 of 23.8% for olorofim versus 24.3% for AmBisome followed by standard care. Olorofim showed a better safety profile with 35.8% drug-related adverse events compared to 63.9% for the comparator, primarily due to fewer renal events. If approved, olorofim would be the first novel mechanism antifungal for invasive aspergillosis in over 20 years.