Clinical Trials Resource Center

Vaginitis

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.

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.

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