Breakthrough therapy designation to olorofim

January 6, 2020 0 By FM

F2G Ltd announced that the US FDA has granted breakthrough therapy designation to its lead first-in-class candidate, olorofim for the indication of ‘treatment of invasive mold infections in patients with limited or no treatment options. This include 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.

The drug is currently being investigated in an open-label single-arm phase 2b study 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.

The phase 2b study for olorofim is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 26 centres are currently open in six countries (AU, BE, ES, NL, USA, IS) and a further 20 will open in 2019/2020. Olorofim is being developed both as IV and oral formulations.