Viamet Release: Positive Interim Clinical Results For VT-1161 To Be Presented At The Infectious Diseases Society For Obstetrics And Gynecology Annual Meeting

-Data from Planned Interim Analysis of Phase 2b Trial in Recurrent Vulvovaginal Candidiasis (RVVC) Demonstrate Potential Significant Advantages Over Current Treatment Paradigms-

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals, Inc. today announced that data from a planned interim analysis of REVIVE, a Phase 2b clinical trial of oral VT-1161 in recurrent vulvovaginal candidiasis (RVVC), will be presented by Dr. Jack Sobel, Dean, Department of Medicine, Wayne State University, at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) annual meeting, to be held August 11-13, in Annapolis, Maryland. VT-1161, the company’s lead product candidate, is a highly potent and selective inhibitor of fungal CYP51.

“RVVC is estimated to occur in 5% to 8% of women during their child-bearing years”

“RVVC is estimated to occur in 5% to 8% of women during their child-bearing years,” stated Dr. Sobel. “There are no approved therapies for RVVC and effectively treating the millions of women suffering from this condition remains a significant clinical challenge. Having an approved therapy to treat RVVC would be very exciting and I am pleased to be working with Viamet in the development of VT-1161 for this condition.”

In preclinical studies, VT-1161 demonstrated highly potent activity against a broad range of Candida species, the causative fungal pathogens of RVVC. A planned interim analysis of the REVIVE study was conducted when approximately 100 patients had completed the first 24 weeks of the trial. Positive efficacy and safety data from the interim analysis and data from preclinical studies of VT-1161 will be presented by Dr. Sobel at IDSOG on Saturday, August 13, beginning at 8:55 a.m. (EST) in the Capitol D Room of the Westin Annapolis Hotel.

“We are pleased to collaborate with Dr. Sobel and our other REVIVE investigators to address this significant unmet medical need,” said Dr. Robert Schotzinger, President and CEO of Viamet. “Because of its outstanding potency, broad therapeutic index and long half-life, we believe VT-1161 may be a highly effective therapy for RVVC and become the first antifungal agent approved for this very common and problematic condition.”

About VT-1161
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51 currently in Phase 2b clinical trials for the treatment of onychomycosis, or fungal nail infection, (the RENOVATE study) and recurrent vulvovaginal candidiasis (the REVIVE study). VT-1161 blocks the production of ergosterol, an essential component of the fungal cell membrane. In preclinical studies, VT-1161 has demonstrated broad-spectrum activity against fungal pathogens, including those species that cause onychomycosis and recurrent vulvovaginal candidiasis. Given the clinical and pre-clinical profile of VT-1161, Viamet believes that it may minimize the safety liabilities that limit the use of current oral antifungal therapies, such as liver toxicity, drug-drug interactions and potential for birth defects. Viamet previously reported robust interim efficacy and safety data from the RENOVATE study and a favorable safety and efficacy profile in a Phase 2a proof-of-concept study in the treatment of acute vulvovaginal candidiasis (AVVC). Top-line final results for both the RENOVATE and REVIVE studies are anticipated in the fourth quarter of 2016.

About the REVIVE Study
REVIVE (REcurrent Vulvovaginal Candidiasis Inhibition: An Oral VT-1161 Tablet Evaluation) is a randomized, double-blind, placebo-controlled, 48-week clinical study of VT-1161 in subjects with recurrent vulvovaginal candidiasis (RVVC). RVVC was defined as three or more episodes of acute vulvovaginal candidiasis, or AVVC (commonly referred to as a vaginal yeast infection), in a 12-month period. The trial is evaluating two dose levels of VT-1161 administered once weekly for either 11 or 23 weeks, following an initial one-week daily loading dose period. At baseline in the REVIVE study, the mean number of patient-reported AVVC episodes per patient in the prior 12 months ranged from 4.5 to 6.0 across the study arms. The trial has enrolled 215 patients at 32 sites throughout the U.S. The primary efficacy endpoint is the proportion of subjects with one or more culture-verified AVVC episodes through 48 weeks.

About Viamet (www.viamet.com)
Viamet discovers and develops breakthrough therapies based on our leadership in metalloenzyme chemistry and biology. Our clinical portfolio includes novel agents to treat both chronic and life threatening fungal infections. We also leverage our metalloenzyme expertise in other therapeutic areas including oncology and orphan diseases. Focusing on the needs of patients and clinicians, we design our drug candidates to achieve superior efficacy and safety profiles compared to currently marketed drugs.

This press release includes forward-looking statements. Actual results may vary materially from these statements. There are many important risks affecting Viamet’s business, 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 are based in the Research Triangle Park region of North Carolina, USA.