FDA tags F2G's olorofim as Breakthrough Therapy for fungal infections

The US drugs regulator has tagged F2G’s olorofim as a potential Breakthrough Therapy for life-threatening fungal infections, pledging to expedite development of the mid-stage candidate.

Based in the UK and Austria, F2G said the FDA granted the designation reserved for potentially game-changing medicines, for treatment of serious aspergillosis mould infections when standard therapies have failed.

The indication the biotech is targeting includes infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species, and makes this the first antifungal agent to be granted Breakthrough Therapy designation.

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.

The designation is granted based on preliminary clinical evidence indicating that the drug could be a substantial improvement over existing therapies on one or more clinically significant endpoints.

If data is supportive the FDA grants a faster Priority Review at the end of the process, allowing for a six-month review instead of the standard 10-month period.

Olorofim is currently being investigated in an open-label single-arm phase 2b study in patients with proven invasive fungal disease or probable invasive aspergillosis, whose disease resists standard therapies or when existing drugs cannot be tolerated.

So far olorofim, which is being developed in both intravenous and oral formulations, has been well tolerated and data from this study were provided to the FDA as part of the company’s submission for Breakthrough Therapy status.

F2G said olorofim, its lead product, belongs to a new class of antifungal agents it has discovered and developed called the orotomides.

Orotomides selectively target fungal dihydroorotate dehydrogenase (DHODH), a different mechanism from that of the currently marketed antifungal agents giving them fungicidal activity against a broad range of rare and resistant fungal mould infections.

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.”