F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim

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 an additional Breakthrough Therapy Designation to its lead first-in-class candidate, olorofim, for the indication of ‘Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy’. This is the second Breakthrough Therapy Designation for olorofim; a designation was granted previously on 11 November 2019 for ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory orintolerant tocurrently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim (formerly F901318) is the first antifungal agent to be granted Breakthrough Therapy Designation.

Olorofim has orphan drug designation in the United States for coccidioidomycosis, an endemic fungal infection with a geographic distribution focused mainly in the desert Southwest of the United States but also including Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. Spread to the brain is particularly feared as it produces a devastating illness that cannot always be controlled with any currently available agent.

Patients with coccidioidomycosis are being studied in an ongoing 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 30 years of cumulative 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.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy Designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

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