FDA: Fast Track Designation of VT-1598 for Valley Fever
VT-1598 has shown high potency against pathogens including molds, yeasts, and multi-drug resistant fungal pathogens.
Viamet announced that the Food and Drug Administration (FDA) has given Fast Track designation to its novel oral drug candidate for the treatment of Valley Fever, VT-1598.
Valley Fever, also known as coccidioidomycosis, is an invasive fungal infection that occurs by inhaling the microscopic spores from the air in affected areas. Preliminary clinical studies have demonstrated the potential for VT-1598 to be a highly potent and highly selective drug with broad-spectrum antifungal activity.
VT-1598, an oral fungal CYP51 inhibitor, has shown high potency against pathogens such as molds, yeasts, and multi-drug resistant fungal pathogens (eg, Candida auris). It has also demonstrated potency against endemic fungi, including Coccidioides, Histoplasma, and Blastomyces species. The investigational agent works by blocking ergosterol production, which is a major part of the fungal cell membrane.
The preclinical profile of VT-1598 suggests it may not carry adverse effects such as hepatotoxicity and drug interactions that hinder the use of current oral antifungals. VT-1598 was previously granted Orphan Drug designation and Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of Valley Fever.
FDA grants fast track designation to VT-1598 for treatment of Valley Fever [news release]. Research Triangle Park, NC: Viamet. http://www.viamet.com/docs/PR_2017_7-13-17.pdf. Published July 13, 2017. Accessed August 11, 2017.