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Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to APX001, the company’s lead drug candidate. APX001 has received orphan drug designation for four distinct indications: the treatment of invasive candidiasis, invasive aspergillosis, coccidioidomycosis, and rare mold infections caused by Scedosporium spp., Fusarium spp., and Mucorales fungi (including Mucor spp., and Rhizopus spp.).
The company was previously granted Qualified Infectious Disease Product (QIDP) designation for APX001 Injection (for intravenous use) and for APX001 Tablets (for oral use), which provides significant development incentives including eligibility for Fast Track designation, priority review and when combined with orphan drug designation, a total of twelve years of marketing exclusivity.
“These government-granted incentives highlight the significant need for safe and effective new antifungal treatments,” said Mike Grey, president and CEO of Amplyx Pharmaceuticals. “The incidence and severity of invasive and drug-resistant fungal infections is increasing, including those caused by rare pathogens. This, coupled with the limited number of antifungal drug classes available, creates an urgent need for the development of novel broad-spectrum antifungal agents.”
The company is advancing APX001 in clinical development, having initiated its Phase 1 clinical program earlier this year. The Phase 1 program evaluates APX001 using both intravenous and oral formulations to address the need for treatment in both the hospital setting and continued convenient treatment after discharge from hospital. The company plans to initiate Phase 2 studies in 2017.
