F2G’s Oral Antifungal Clears Phase III Hurdle - European Biotechnology Magazine

F2G and Shionogi Announce Positive Topline Results From Global Phase 3 OASIS Study Evaluating Oral Olorof

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 eit…

First Novel Antifungal for Aspergillus in 20 Years Succeeds in Phase III

F2G and Shionogi have reported positive Phase III results for the antifungal drug olorofim in patients with invasive aspergillosis who are not eligible for standard azole therapy. If approved based on this data, olorofim would become the first antifungal agent with a novel mechanism of action for invasive aspergillosis in over two decades.  “Invasive fungal infections remain difficult to treat and can be life-threatening especially in immunocomp…

F2G’s oral antifungal clears Phase III hurdle - European Biotechnology Magazine

UK antifungal specialist F2G and Japanese partner Shionogi have announced positive topline results from the global Phase III OASIS trial of olorofim in patients with invasive aspergillosis, a life-threatening fungal infection that mainly affects immunocompromised patients. The post F2G’s oral antifungal clears Phase III hurdle appeared first on European Biotechnology Magazine.

Antifungal from F2G, Shionogi succeeds in Phase 3 study

F2G and Shionogi released positive Phase 3 data on Thursday morning, giving the companies a potentially clear path to approval for their antifungal drug. The companies said their treatment called olorofim performed as well as ...