Starpharma (ASX:SPL) has announced two phase 3 trials of VivaGel BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective demonstrating statistically significant superiority compared to placebo in preventing rBV based on topline data.
The company said it intends to submit a marketing application to the FDA for VivaGel BV for prevention of rBV based on the results.
The two double-blind, randomised, placebo-controlled trials, SPL7013-017 (017 US trial) and SPL7013-018 (018 European trial), were identical in design and enrolled 1,223 women who had a history of rBV.
A history of rBV was defined as at least three episodes of BV in the preceding 12 months. Trial participants used either VivaGel BV or placebo gel on alternate days for 16 weeks.
The primary endpoint of both studies was BV recurrence at or by week 16 as diagnosed by clinical findings.
In the 017 US trial, the rate of BV recurrence at or by week 16 in the VivaGel BV group was a statistically significant 44.2 per cent compared to 54.3 per cent in the placebo group. Actual BV recurrence rates, not imputing missing data to failure, were even lower at 34.9 per cent for VivaGel BV and 46.6 per cent for placebo.
In the 018 European trial, the rate of BV recurrence at or by week 16 in the VivaGel BV group was just 15.7 per cent compared to 22.6 per cent in placebo. In comparison, the 16-week Historical Recurrence Rate (without intervention) for the 018 European trial participants was approximately 50 per cent.
According to CEO Dr Jackie Fairley, “We are delighted to report these successful phase 3 trial results, in which VivaGel BV has demonstrated compelling efficacy in all six primary and secondary efficacy measures. Our NDA for VivaGel BV for both treatment and rBV is well-advanced, and we’ll be using these data to complete the clinical package for submission to the FDA and other regulatory authorities.
“There’s a desperate need for new therapeutic options for BV, a serious condition that affects nearly 1 in 3 women globally. The fact that VivaGel BV is not a conventional antibiotic and specifically targets BV bacteria, makes it a particularly appealing solution for patients. It also represents a highly attractive commercial proposition especially given it will be first in class for the prevention of rBV. VivaGel BV has potential to gain a significant share of this market, which is estimated to be in excess of US$1 billion per annum globally,” added Dr Fairley.