F2G has secured breakthrough therapy designation to olorofim (formerly F901318) from the US Food and Drug Administration (FDA) for the treatment of invasive mold infections.
The breakthrough therapy designation is for the use of olorofim in patients having limited or no treatment options, and also those who are intolerant to currently available therapy for their invasive mold infections – including aspergillosis refractory, and infections caused by Lomentospora prolificans, Scedosporium, and Scopulariopsis species.
F2G is a UK- and Austria-based biotech company engaged in developing therapies for life-threatening systemic fungal infections.
Olorofim, which is an antifungal agent, is presently being studied in an open-label single-arm phase 2b clinical trial in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to existing agents.
Professor Sharon Chen – Westmead Hospital Sydney and Principal Investigator for the Phase 2b study said: “This news is very exciting for clinicians caring for patients with these very serious, and devastating mold infections. We have had limited treatment options for many years and now the news about olorofim brings realistic hope that we can cure these previously treatment–refractory infections.”
The antifungal agent has been well tolerated across 10 plus years of patient dosing days with a median therapy duration of 12 weeks, said F2G. The company said that preliminary data from the phase2b study were presented to the FDA as part of the submission for the breakthrough therapy designation.
Ian Nicholson – CEO of F2G said: “The granting of FDA Breakthrough Therapy designation is a truly transformational step for our company and will support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections.
“Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.”
Ian Nicholson said that the phase 2b trial is on track with more than 40 patients enrolled across Europe, Australia, and the US.