September 11, 2017
Symbiomix Therapeutics issued results of a phase III, randomized, double-blind, dose-ranging, placebo-controlled, multicenter study of Solosec for the treatment of bacterial vaginosis (BV). In the SYM-1219-301 study, women with BV were randomized to 2g secnidazole or placebo, each administered as a single oral dose. The 2g dose of secnidazole proved superior to placebo on all primary and secondary outcomes and was well-tolerated. In the modified intent-to-treat (mITT) population of 189 women, clinical outcome responder rates were 53.3% for 2g secnidazole compared with 19.3% for placebo (p<0.001). The clinical outcome responder rate analysis was 58.9% for 2g secnidazole compared with 24.6% for placebo (p<0.001) when women with abnormal discharge that is inconsistent with BV were included as clinical outcome responders. Clinical cure rates based on the 2016 FDA guidance of seven to 14 days after treatment were 64.0% for 2g secnidazole compared with 26.4% for placebo. Based on the investigator’s clinical assessment at the test of cure, significantly more patients receiving single-dose secnidazole 2g compared to placebo required no additional BV treatment (68.0% vs 29.6%; p<0.001). The overall adverse event rate was 34.4% for single-dose secnidazole 2g compared to 21.9% for placebo. Most adverse events were mild or moderate in intensity and non-serious. The FDA accepted the NDA for Solosec oral granules in March 2017. In accordance with the FDA’s priority six-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 2017.
August 22, 2016
NovaDigm Therapeutics reported
results of a phase IIa study of NDV-3A for
recurrent vulvovaginal candidiasis (RVVC).
The multicenter, double-blind, randomized,
placebo-controlled study enrolled 188 patients
over 20 U.S. study sites. Patients were
assigned one dose of either 300μg NDV-3A
immunotherapy or a placebo. The study met
its primary endpoint of safety and tolerability.
There were no significant differences
between NDV-3A and placebo for injection
site reactions and systemic reactions of
grade three or greater. A single dose of NDV-
3A generated very rapid and robust immune
responses. Exploratory efficacy measures
based on patient-reported symptom scores
showed a trend toward significance at the
12-month follow-up period (p=0.10). Younger
patients showed higher efficacy rates. In
patients under 40 years of age (80% of the
study population), NDV-3A recipients were
about 50% more likely to be recurrence free
at the end of the study compared to placebo
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.