Starpharma Holdings Ltd. said two phase 3 trials evaluating VivaGel BV to treat recurrent bacterial vaginosis, or rBV, achieved their primary objective of statistically significant efficacy compared to placebo.
A U.S. trial, SPL7013-017, and a European trial, SPL7013-018, were identical in design and enrolled 1,223 women who had at least three episodes of BV in the preceding 12 months. Both trials had a primary endpoint of BV recurrence at or by week 16 as diagnosed by clinical findings.
Recurrence rates in the VivaGel BV and placebo groups at or by week 16 were 44.2% and 54.3%, respectively, in the U.S. trial, and 15.7% and 22.6%, respectively, in the European trial.
VivaGel also showed statistically significant benefits compared with placebo in five secondary efficacy endpoints, including time to recurrence of BV and reduced recurrence of BV by clinical findings. Additionally, reduced recurrence by the trials' primary and secondary efficacy endpoints was observed in the VivaGel BV group throughout the 12-week follow-up period off-treatment.
Starpharma said the treatment also showed "excellent" safety and tolerability.
The company plans to submit a new drug application for VivaGel BV to the U.S. Food and Drug Administration, as well as expand the treatment's indications in Europe to include prevention of recurrent bacterial vaginosis.
VivaGel BV is a water-based gel used to treat bacterial vaginosis, a type of vaginal inflammation caused by an imbalance of naturally occurring bacterial flora. The drug has European regulatory approval for the topical treatment and rapid relief of bacterial vaginosis. BV affects about 30% of women in the U.S.