Viamet Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to VT-1598 for the treatment of coccidioidomycosis, or Valley Fever. VT-1598 is a selective, orally available inhibitor of fungal CYP51 that has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for Valley Fever.
Valley Fever, a common lung infection in the southwestern U.S., affects approximately 150,000 people in the U.S. annually. Approximately 5% to 10% of Valley Fever sufferers develop a more severe form of the disease and some of these patients will develop a chronic pulmonary infection, which can be associated with dissemination of the fungal infection to other parts of the body. While current therapies are effective in some patients, they are often poorly tolerated and morbidity and mortality remain significant.
In preclinical studies, VT-1598 has demonstrated significantly greater potency against Coccidioides clinical isolates than fluconazole, an antifungal therapy commonly used as the primary treatment for Valley Fever. In preclinical models of Valley Fever, oral VT-1598 was highly effective in treating disease localized to the central nervous system, the most difficult to treat site of dissemination in humans.
“We are pleased that the FDA has granted orphan status to VT-1598 for the treatment of Valley Fever. We believe that the unique properties of VT-1598 provide the potential for a new treatment option for patients suffering from this disease,” commented Robert Schotzinger, M.D., Ph.D., CEO of Viamet. “Valley Fever is a disease with considerable unmet need and we look forward to progressing this very exciting product candidate.”