Posted Jul. 14, 2017 at 8:30 a.m.

Durham biotech's valley fever therapy is on FDA fast track

Published: 2017-07-14 08:30:00
Updated: 2017-07-14 08:30:00


​Durham-based Viamet Pharmaceuticals has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its anti-fungal agent VT-1598, a novel oral therapy 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,” Robert Schotzinger, M.D., Ph.D., president and CEO of Viamet, said in a news release.

Fast Track designation is intended to speed the development and review of new drug candidates that potentially could treat serious conditions and fill unmet medical needs. The FDA previously granted two other helpful designations for VT-1598: Orphan Drug status and Qualified Infectious Disease Product status.

ViametValley fever, also known as coccidioidomycosis, is an infection caused by the fungal pathogen Coccidioides. It is heavily concentrated in the Southwestern United States, as well as parts of Mexico, Central and South America, where the spores of Coccidioides live in the soil.

Patients with chronic forms of the illness experience flu-like symptoms that can range from mild to severe, including fever, cough, chest pain, chills, night sweats, headache, fatigue, joint aches and rash.

Many of the estimated 150,000 annual cases of valley fever are either self-limited or resolve with current therapies. However, some patients develop a more severe and debilitating form of the disease.

“Each year, approximately 5-10 percent of the patients that contract valley fever develop chronic pulmonary or disseminated disease, which can be deadly,” Schotzinger said. “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 works by blocking the production of ergosterol, an essential component of the fungal cell membrane. Based on preclinical tests, Viamet said VT-1598 may avoid the side effects that limit the use of current oral antifungal therapies, such as liver toxicity and drug-drug interactions.

Viamet's pipelineViamet discovers and develops therapies based on metalloenzyme chemistry and biology. In addition to anti-fungals, the company is working on other therapeutic areas including oncology and orphan diseases. Orphan diseases are rare conditions that affect fewer than 200,000 U.S. patients per year.

Viamet is a privately held company backed by venture capital. It was founded in 2005 by entrepreneur and inventor Holden Thorp, a chemistry professor at the University of North Carolina at Chapel Hill who went on to become chancellor of UNC before being named provost of Washington University in St. Louis in 2013.

(C) N.C. Biotechnology Center

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