F2G Receives US FDA Breakthrough Therapy Designation for Olorofim
In Phase 2b development for the treatment of life-threatening fungal infections
First antifungal agent to receive Breakthrough Therapy designation
MANCHESTER, UK / VIENNA, Austria – November 11, 2019 – F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.
Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 10 years of patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy designation submission.