Austria-based biotech company F2G Ltd revealed on Friday the receipt of US Food and Drug Administration (FDA) breakthrough therapy designation for its lead first-in-class candidate, olorofim (formerly F901318) for the indication of 'Treatment of invasive mold infections in patients with limited or no treatment options.

The company added that Olorofim is the first antifungal agent to be granted US FDA Breakthrough Therapy designation for the indication of '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'.

Currently, Olorofim is being investigated in the company's 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.

About 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, revealed the company.

In conjunction with the results, the company said Olorofim has been well tolerated across more than ten years of patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA for the Breakthrough Therapy designation submission, concluded the company.