March 21, 2016
Viamet Pharmaceuticals reported positive results from a planned interim analysis of REVIVE, its ongoing phase IIb trial of VT-1161 for the treatment of recurrent vulvovaginal candidiasis (RVVC). REVIVE is a randomized, double-blind, placebo-controlled, 48-week clinical trial of VT-1161 in patients with RVVC. 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 in each. At baseline, the mean number of AVVC episodes per patient in the prior 12 months ranged from 4.5 to 6 across the study arms. The trial enrolled 215 patients at 32 sites throughout the U.S. A planned interim analysis was conducted when approximately 100 patients had completed the first 24 weeks of the trial. Across the four VT-1161 treatment arms, only 3% of the patients suffered a recurrence of AVVC through week 24 as compared to 48% of patients in the placebo arm. Notably, in the two high-dose VT-1161 arms there was not a single patient who suffered a recurrence through week 24. In addition, safety data from the interim analysis population demonstrated that VT-1161 was well tolerated with a favorable safety profile. In particular, there was no evidence of an adverse effect of VT-1161 on liver function. Top-line final results are expected in the fourth quarter of 2016.
March 3, 2014
Viamet Pharmaceuticals released results
of an ongoing phase II study of VT-1161 in
patients with moderate to severe acute vulvovaginal
candidiasis (AVVC). The AVVC study
will enroll approximately 48 patients in three
VT-1161 oral dose groups v. oral fluconazole,
the current clinical standard of care. Both clinical
and mycologic endpoints were evaluated at the
test-of-cure visit on Day 28. Effective clinical cure
was based upon an improvement in six clinical
signs and symptoms of AVVC. Patients were
enrolled in the low-dose VT-1161 group, the
mid-dose VT-1161 group and the fluconazole
control group. In the intent-to-treat population
(all randomized patients who received at least
one dose of study drug), effective therapeutic
cure was achieved in 71% of patients in the
low-dose VT-1161 arm, 92% of patients in the
mid-dose VT-1161 arm and 80% of patients
in the fluconazole arm. VT-1161 was found
to be well-tolerated with no serious adverse
events reported, and no patient discontinuing
VT-1161 due to an adverse event. Based upon
the favorable safety and tolerability profile, an
additional high-dose cohort currently is being
enrolled. Results from this final patient cohort
are expected late in the second quarter of 2014.
Study continues on oral VT-1161 in a phase II
trial in patients with interdigital tinea pedis as a
precursor to a larger phase IIb study in patients
with onychomycosis, which Viamet expects to
initiate later in 2014.
May 30, 2011
StarPharma reported results from a phase II trial of VivaGel for the treatment of bacterial vaginosis. This double-blind, randomized, placebo controlled, dose-ranging study enrolled 132 women who received 0.5%, 1% or 3% gel or placebo gel administered vaginally for seven consecutive days. The primary endpoint was Clinical Cure as defined by no abnormal discharge. VivaGel 1% resulted in 74% of subjects achieving Clinical Cure two to five days after completion of therapy compared with 22% in the placebo group (P≡0.0002). This effect was sustained: two to three weeks after completion of therapy, 46% of subjects achieved Clinical Cure compared with 12% for the placebo (P≡0.006). In addition, unpleasant vaginal odor was cured in 78% of the VivaGel treated subjects. The incidence of adverse events was similar across all placebo gel and VivaGel groups.
April 1, 2002
Results were reported from a phase II randomized, placebo-controlled trial evaluating CTV-05, a strain of human Lactobacillus, for treatment of bacterial vaginosis. The drug was tested in over 400 female subjects as an adjunct to standard metronidazole therapy. Treatment with CTV-05 resulted in vaginal colonization by lactobacillus crispatus in 62% of subjects at 30 days, compared to only 2% of placebo subjects. However, clinical cure rates at 30 days, the primary endpoint of the trial, were not significantly improved with CTV-05 treatment. Satisfactory cure rates were reported in approximately 50% of subjects in both groups. Clinical cure at 30 days was observed in 70% of colonized subjects who received the active drug, compared to 47% who were non-colonized and received placebo, showing that while CVT-05 does not significantly improve cure rates, it does significantly increase colonization rates. CVT-05 is being developed by The Medicines Company.