FDA Grants Fast Track Designation to VT-1598 for Treatment of Valley Fever

Viamet Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VT-1598, a novel oral agent for the treatment of coccidioidomycosis, also known as Valley Fever. Valley Fever is an invasive fungal infection that is highly concentrated in the San Joachin Valley in California (where Coccidioides immitis is the predominant pathogen). It is also present in central and southern Arizona, western Texas, southern New Mexico, and parts of Mexico and Central and South America (where Coccidioides posadasii is the predominant pathogen). Infection occurs by inhalation of the microscopic fungal spores from the air in the affected regions. Current therapies for Valley Fever are limited by significant safety concerns, drug interactions and poor efficacy.

Fast Track designation is designed to facilitate the development and expedite the review of new drug candidates to treat serious conditions and fill an unmet medical need. Previously, the FDA granted orphan drug designation and Qualified Infectious Disease Product (QIDP) designation to VT-1598 for the treatment of Valley Fever.

“The FDA’s decision to award Fast Track designation to VT-1598 highlights the high unmet needs in the treatment of Valley Fever, and provides a process for Viamet to work closely with the FDA to bring this treatment to patients in an expedited manner,” said Robert Schotzinger, M.D., Ph.D., President and CEO of Viamet. “Each year, approximately 5-10% of the patients that contract Valley Fever develop chronic pulmonary or disseminated disease, which can be deadly. Preclinical studies have shown that VT-1598 has the potential to be a highly potent and highly selective antifungal agent with broad spectrum activity, and we look forward to continuing the advancement of this promising candidate.”

VT-1598 is one of several product candidates with best-in-class potential in development by Viamet. VT-1161, Viamet’s lead product candidate, recently completed two Phase 2b clinical trials, RENOVATE and REVIVE, which investigated the oral treatment of onychomycosis, a highly prevalent fungal infection of the nail, and recurrent vulvovaginal candidiasis, or recurrent yeast infection, a common and difficult to treat condition in women.