Mycovia Begins Clinical Trials of Anti-fungal for Yeast Infections

Durham-based Mycovia Pharmaceuticals, formerly Viamet Pharmaceuticals, has begun two Phase 3 clinical trials of its lead drug candidate for treating recurrent yeast infections in women.

The trials will evaluate the safety and efficacy of VT-1161, an oral anti-fungal medicine being developed to treat recurrent vulvovaginal candidiasis (RVVC) and onychomycosis, a common infection of fingernails and toenails.

The medicine is intended to have greater selectivity, fewer side effects and improved potency than current anti-fungals, Mycovia said in a news release.

“VT-1161 is highly potent against a broad spectrum of Candida species, the primary fungal pathogen responsible for RVVC, and in recently completed Phase 2 studies clinically demonstrated a durable response against re-infection,” said Stephen Brand, Ph.D., senior vice president of clinical development at Mycovia. “VT-1161 has the potential to be a best-in-class treatment option for patients suffering from RVVC and to be the first FDA-approved treatment for this common disease.”

Mycovia will conduct two multi-center, randomized, double-blind, placebo-controlled trials, called VIOLET, in North America, Europe and Japan with about 60 global sites and 300 randomized patients per study. The studies should be completed in the second half of 2020 in anticipation of regulatory submissions in the United States, the European Union and Japan, the company said.

RVVC means three or more infections a year

RVVC is generally defined as three or more yeast infections per year. It affects about 5 to 8 percent of women. 

While the physical symptoms of RVVC – itching, irritation, soreness and damage to the skin – can be distressing, the emotional and psychological consequences can also affect quality of life.

“There are currently no approved treatment options for RVVC in the U.S. today, despite the negative effects that the condition has on millions of women,” said Patrick Jordan, chief executive officer of Mycovia. “Women’s health is an underserved therapeutic area with significant unmet need.”

RVVC is typically treated each time an acute infection occurs, sometimes followed by long-term suppressive therapy with oral fluconazole, a drug with a limited antifungal spectrum that has been associated with drug-drug-interactions and potential pregnancy effects, said Jack D. Sobel, M.D., dean of Wayne State University’s School of Medicine and one of the clinical investigators in the VIOLET studies.

VT-1161 “demonstrated a high degree of efficacy and safety” during a Phase 2 study, Sobel said. “The low re-infection rates observed in the VT-1161-treated patients were very impressive compared to other therapies previously studied in RVVC.”

VT-1161 has received Qualified Infectious Disease Product and Fast Track designations by the U.S. Food and Drug Administration. The designations provide incentives including extended patent protection and expedited regulatory reviews to companies developing new drugs that could satisfy unmet medical needs.

More information on the VIOLET Phase 3 trials can be found at ClinicalTrials.gov under the identifier numbers NCT03561701 and NCT03562156.

Mycovia was created earlier this year following the acquisition of Viamet Pharmaceuticals and VT-1161 by Raleigh-based NovaQuest Capital Management. NovaQuest manages over $1.8 billion in life science and healthcare company investments. 

Prior to the formation of NovaQuest Capital Management in 2010, many of the company’s partners and senior executives were part of the former NovaQuest business unit at Durham-based Quintiles Transnational Holdings (now IQVIA), a global giant in contract clinical research and data science.