Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antifungal candidate, fosmanogepix (APX001), for seven indications. 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 is investigating the safety and efficacy of fosmanogepix in its ongoing global Phase 2 clinical program.
Invasive fungal infections are a significant cause of morbidity and mortality in critically ill and immune-compromised patients. With the rise of increasingly difficult-to-treat fungal infections, particularly those caused by multidrug-resistant strains such as Candida auris, there is a serious and growing public health threat. In addition, no new classes of antifungal drugs have been approved since 2001, and many of the existing antifungal agents are difficult to use, poorly tolerated or ineffective due to the rise of drug-resistant strains.
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,
said Ciara Kennedy, Ph.D.,
president and CEO of Amplyx.
Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. The two formulations of fosmanogepix have previously been granted Qualified Infectious Disease Product (QIDP) designation for the four qualified fungal pathogens including Candida species, Aspergillus species, Coccidioides species and Cryptococcusspecies. QIDP designation also makes fosmanogepix eligible for priority review and an additional five years of U.S. market exclusivity, if approved.