Olorofim Receives Breakthrough Therapy Designation for Invasive Fungal Infections

The Food and Drug Administration has granted Breakthrough Therapy designation to olorofim (formerly F901318; F2G) for the 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 part of a new class of antifungal agents called the orotomides, discovered and developed by the Company. The orotomides work by targeting the enzyme, dihydroorotate dehydrogenase (DHODH), in the de novo pyrimidine biosynthesis pathway. The investigational drug is being developed in both intravenous (IV) and oral formulations.

The Breakthrough Therapy designation is based on preliminary data from the ongoing global, open-label, single-arm, phase 2b FORMULA-OLS study evaluating olorofim in patients with proven invasive fungal disease or probable invasive aspergillosis and either refractory disease, resistance, or intolerance to available agents (N=100).  

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, 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.”

For more information visit f2g.com.