Amplyx bags FDA fast track designation for two its antifungal candidates, for 7 indications

Amplyx was granted the FDA’s Fast Track designations for two of its lead antifungal candidate intravenous (IV) and oral formulations, fosmanogepix (APX001), for seven indications, the company said Monday ina press release.

These indications include treatment of invasive candidiasis, treatment of invasive aspergillosis, treatment of scedosporiosis, treatment of fusariosis, treatment of mucormycosis, treatment of cryptococcosis and treatment of coccidioidomycosis, Amplyx said. The company is also investigating the safety and efficacy of fosmanogepix in its ongoing global Phase 2 clinical program.

Ciara Kennedy, the CEO of Amplyx said: “The FDA Fast Track designation for fosmanogepix is an important step forward in addressing the need for new medicines to treat fungal infections. With fosmanogepix and its novel mechanism of action and robust clinical program, we are directly addressing the threat of invasive fungal infections by developing innovative therapies for immunocompromised patients who need them the most. We look forward to working closely with the FDA as we continue to advance fosmanogepix through clinical development.”