22 March 2018 - - The US Food and Drug Administration has granted San Diego, California-based drug discovery company Amplyx Pharmaceuticals a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, its lead antifungal product candidate, the company said.
Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis.
This new QIDP status expands the eligible population to include the treatment of cryptococcosis.
APX001 is the prodrug of APX001A, which is a first-in-class small molecule drug candidate that inhibits the highly conserved fungal enzyme Gwt1, compromising growth of major fungal pathogens, including Candida and Aspergillus.
The novel mechanism of action of APX001 translates into a highly versatile drug that demonstrates activity against drug-resistant strains and can be delivered in both oral and intravenous formulations.
In multiple nonclinical studies, APX001A has shown broad-spectrum activity against common species of Candida spp., and Aspergillus spp., including multi-drug resistant strains including Candida auris and rare, hard-to-treat molds including Fusarium spp., Scedosporium spp., and fungi from the Mucorales order.
Amplyx Pharmaceuticals is developing first-in-class products for life-threatening infections, with a near-term focus on deadly fungal pathogens in vulnerable, immune compromised patients.
The company's drug discovery and development efforts have been supported by significant venture investment and more than USD10 m in grants from the National Institutes of Health.