Viamet Reports Positive Results from REVIVE Phase 2b Trial of Oral VT-1161 in Recurrent Vulvovaginal Candidiasis

-48 Week Results Demonstrate Strong Clinical Benefit and Very
Favorable Safety Profile-

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–#Phase2bViamet
Pharmaceuticals, Inc.
today reported positive efficacy and safety
results from REVIVE (Recurrent Vulvovaginal Candidiasis Inhibition: an
Oral VT-1161 Tablet Evaluation), a Phase 2b clinical trial of VT-1161
for the treatment of recurrent vulvovaginal candidiasis, or RVVC. RVVC
is 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. VT-1161, the company’s lead product candidate, is a
highly potent and selective, orally available inhibitor of fungal CYP51.

The study met its primary endpoint of proportion of subjects with one or
more culture-verified AVVC episodes through 48 weeks. In the per
protocol analysis, which includes patients evaluable through 48 weeks,
the recurrence rate in the placebo arm was 66%. In contrast, patients in
all VT-1161 arms had markedly lower rates of AVVC recurrence. The
proportion of subjects with one or more culture-verified AVVC episodes
was 0% to 11% in the four VT-1161 arms of the study with all arms
achieving statistical significance vs. placebo. Throughout the study,
VT-1161 was very well tolerated with a favorable safety profile, and the
incidence of adverse events was lower in all of the VT-1161 arms
compared to placebo. In addition, no patient in any VT-1161 arm
discontinued the study early due to an adverse event or laboratory
abnormality. There was also no evidence of an adverse effect of VT-1161
on liver function.

“It is estimated that RVVC affects 5% to 8% of U.S. women during their
child-bearing years and has a significant negative impact on their
overall quality of life, affecting them emotionally, physically, and
economically. Despite the number of women affected by this disease,
there are currently no approved therapies for RVVC in the U.S.,”
commented Robert Schotzinger, M.D., Ph.D., CEO of Viamet. “VT-1161 has
demonstrated a high degree of potency against Candida species,
the causative fungal pathogens responsible for RVVC, demonstrating the
potential to be a first-in-class treatment option for these patients. It
has shown a robust oral pharmacokinetic profile and maintained a
favorable safety profile in previous studies. These very positive
results from our REVIVE trial suggest that VT-1161 has the potential to
be a first-in-class, highly effective and safe treatment option for
patients with RVVC. We look forward to presenting the full study results
at a future scientific conference.”

REVIVE 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 AVVC 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 an AVVC infection, and had
completed treatment of the active infection with fluconazole, an
antifungal agent approved in the U.S. for the treatment of AVVC. The
primary efficacy endpoint was the proportion of subjects with one or
more culture-verified AVVC episodes through 48 weeks.

About VT-1161
VT-1161 is a potent and selective,
orally-administered inhibitor of fungal CYP51 which recently completed
Phase 2b clinical trials for the treatment of recurrent vulvovaginal
candidiasis (RVVC) and onychomycosis, or fungal nail infection. 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 Candida species and
dermatophytes, including those species that cause RVVC and
onychomycosis. Given the clinical and pre-clinical profile of VT-1161,
the Company 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.

About RVVC
Recurrent vulvovaginal candidiasis (RVVC) is
defined as the occurrence of three or more episodes of acute
vulvovaginal candidiasis (AVVC) 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.

Contacts

MacDougall Biomedical Communications
Stefanie Tuck, +1 781-235-3060
stuck@macbiocom.com