Novel Antifungal Gains Fast Track Designation for Seven Indications

The Food and Drug Administration (FDA) has granted Fast Track designations to both the oral and intravenous formulations of fosmanogepix (APX001; Amplyx Pharmaceuticals) for 7 antifungal indications, including treatment of: invasive candidiasis, invasive aspergillosis, scedosporiosis, fusariosis, mucormycosis, cryptococcosis and coccidioidomycosis.

Fosmanogepix is a broad spectrum antifungal with a novel mechanism of action that has demonstrated activity against drug-resistant strains in nonclinical studies. Fosmanogepix contains the active moiety, manogepix (APX001A), that compromises the growth of major fungal pathogens by inhibiting the highly conserved fungal enzyme Gwt1. 

The Company is currently investigating the drug in a phase 2 trial as a first-line treatment for patients with fungal infections. Fosmanogepix has also been granted Qualified Infectious Disease Product designation for 4 fungal pathogens and Orphan Drug designation for 6 fungal pathogens by the FDA.

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“With fosmanogepix […] we are directly addressing the threat of invasive fungal infections by developing innovative therapies for immunocompromised patients who need them the most,” said Ciara Kennedy, PhD, president and CEO of Amplyx. “We look forward to working closely with the FDA as we continue to advance fosmanogepix through clinical development.”

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