Viamet Release: Data On VT-1161 For The Treatment Of RVVC To Be Presented At The Infectious Diseases Society For Obstetrics And Gynecology Annual Meeting
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals, Inc. today announced that results from the Company’s REVIVE study, a Phase 2b clinical trial of VT-1161 in the treatment of patients with recurrent vulvovaginal candidiasis (RVVC), will be highlighted in an oral presentation at the upcoming Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held August 10 to 12 in Park City, Utah. The presentation will be given by Jack Sobel, M.D., one of the world’s foremost authorities on vaginal yeast infections, and a clinical investigator in the REVIVE clinical trial. VT-1161, a novel inhibitor of fungal CYP51, recently completed a Phase 2b trial for the treatment of RVVC, a common condition for which there are currently no approved therapies in the United States. It is estimated that RVVC afflicts 5 to 8 percent of women of child-bearing age, and can be a source of significant concern and discomfort leading to a negative impact on quality of life.
Additional details of the REVIVE study presentation are as follows:
Title: | Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients with Recurrent Vulvovaginal Candidiasis | |||
Date/Time: |
Thursday, August 10, 2017, 1:45 pm – 1:55 pm (Mountain) |
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Location: | Scientific Oral Presentation Session 1, Renoir Room, The Chateaux Deer Valley | |||
About the Phase 2b REVIVE study
REVIVE (REcurrent Vulvovaginal
Candidiasis Inhibition: an Oral VT-1161 Tablet Evaluation)
was a randomized, double-blind, placebo-controlled, 48-week clinical
trial of VT-1161 in patients with RVVC. The trial evaluated two dose
levels of VT-1161 (150 mg and 300 mg) administered once weekly for
either 11 or 23 weeks, following an initial one-week daily loading dose
period. The trial enrolled 215 patients at 32 sites throughout the U.S.
At baseline, the mean number of vulvovaginal candidiasis episodes per
patient in the prior 12 months ranged from 4.6 to 5.2 across the study
arms. Patients were eligible to enroll in the trial if they had a
documented history of RVVC, presented to the physician with a
vulvovaginal candidiasis infection, and had completed treatment of the
active infection with fluconazole, an antifungal agent approved in the
U.S. for the treatment of vulvovaginal candidiasis. The primary efficacy
endpoint was the proportion of subjects with one or more
culture-verified vulvovaginal candidiasis episodes through 48 weeks.
About VT-1161
VT-1161 is a potent and selective,
orally-administered inhibitor of fungal CYP51 which recently
successfully completed Phase 2b clinical trials for the treatment of
onychomycosis, or fungal nail infection, and recurrent vulvovaginal
candidiasis (RVVC), a common and difficult to treat infection in women
of child bearing age. 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 both
dermatophytes and Candida species, including those species that
cause onychomycosis and RVVC. Given the clinical and preclinical profile
of VT-1161, Viamet believes that it may avoid the side effects that
limit the use of current oral antifungal therapies, such as liver
toxicity and drug-drug interactions. The U.S. Food and Drug
Administration (FDA) has granted Qualified Infectious Disease Product
(QIDP) and Fast Track designations to VT-1161
for the treatment of RVVC.
About RVVC
Recurrent vulvovaginal candidiasis (RVVC) is
defined as the occurrence of three or more episodes of vulvovaginal
candidiasis within a 12-month period. RVVC is estimated to occur in 5%
to 8% of women in the United States during their child-bearing years.
The infection involves the vaginal mucosa and surrounding tissues and
can be a source of significant discomfort. RVVC is ranked by patients
above migraine and similar to asthma and chronic obstructive pulmonary
disease with regard to its negative impact on quality of life and also
results in a significant loss of work time. There are currently no
approved therapies in the US for the treatment of RVVC.
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., VPS-3, Inc. and Viamet Pharmaceuticals (Bermuda), Ltd. The Viamet group of companies are based in the Research Triangle Park region of North Carolina, USA and Hamilton, Bermuda.
MacDougall Biomedical Communications
Stefanie Tuck, +1 781-235-3060
stuck@macbiocom.com