RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals, Inc. today announced that data from a Phase 2a study of VT-1161, the Company’s lead novel, oral antifungal compound, will be presented at the Infectious Diseases Society for Obstetrics and Gynecology Annual Meeting, to be held from August 6-8, 2015, in Portland, OR. In addition, the company will also provide an update on the ongoing REVIVE (REcurrent Vulvovaginal Candidiasis Inhibition; an Oral VT-1161 Tablet Evaluation) study, a Phase 2b clinical trial of VT-1161 for the oral treatment of recurrent vulvovaginal candidiasis (RVVC).
Stephen Brand, Ph.D., Viamet’s Director of Portfolio Management, will present, “Efficacy and Safety of Oral VT-1161, a Novel and Selective Inhibitor of Fungal CYP51, in a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study (NCT01891331) in Patients with Acute Vulvovaginal Candidiasis.” This study demonstrated the potent antifungal activity and robust safety profile of oral VT-1161 in the treatment of moderate-to-severe acute vulvovaginal candidiasis (AVVC), a very common fungal infection among women. The results also indicate the potential activity of VT-1161 in recurrent vulvovaginal candidiasis (RVVC), defined as the occurrence of three or more AVVC infections within a 12-month period.
“We believe that VT-1161 has the potential to be a significant new treatment option for patients with RVVC, a condition affecting 4-6 million women in the U.S. for which there is no currently approved therapy,” commented Robert Schotzinger, MD, PhD, CEO of Viamet. “We are also pleased to announce that our ongoing REVIVE Phase 2b clinical trial in RVVC has surpassed 50% enrollment, and we remain on track to fully enroll the study during the fourth quarter of 2015.”
RVVC is commonly defined as the occurrence of three or more acute vulvovaginal Candida infections within a 12-month period. The infection involves the vaginal mucosa as well as the surrounding areas. RVVC can be a source of significant discomfort and leads to loss of work time as well as a significant negative impact on quality of life. There are currently no approved agents in the United States for the treatment of RVVC, which afflicts between 5% to 8% of women of child-bearing age.
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51. VT-1161 blocks the production of ergosterol, an essential component of the fungal cell membrane. In in vitro and in vivo studies, VT-1161 has demonstrated broad spectrum activity against both Candida and dermatophyte species, including those species that cause recurrent vulvovaginal candidiasis (RVVC) and onychomycosis. Because VT-1161 is highly selective for fungal CYP51, the Company believes that it may avoid the side effects that limit the use of commonly prescribed oral antifungal therapies, such as liver toxicity and drug-drug interactions.
About Viamet (www.viamet.com)
Viamet is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics based on a proprietary metalloenzyme chemistry platform. The Company is using this platform to design drugs that are expected to have greater selectivity and safety as well as improved potency compared to currently available therapies. The Company’s initial product candidates include a portfolio of highly potent and selective novel antifungal agents. The Company is also conducting research programs in oncology and certain orphan diseases that leverage the Company’s core expertise in metalloenzyme drug discovery.
This press release includes forward-looking statements. Actual results may vary materially from these statements. There are many important risks affecting Viamet’s business and VT-1161, including that clinical trials may not be commenced, or if commenced, may not be successful, regulatory approvals may not be obtained and approved products, if any, may not achieve commercial success. The Viamet group of companies includes Viamet Pharmaceuticals Holdings, LLC and its operating subsidiaries, Viamet Pharmaceuticals, Inc., VPS-2, Inc. and VPS-3, Inc. The Viamet group of companies is based in the Research Triangle Park region of North Carolina, USA.