Dare Biosciences Inc. (NASDAQ:DARE) has announced encouraging top-line DARE-BVFREE Third Phase double-blinded, randomized, placebo-controlled clinical study results. The study evaluated the company’s DARE-BV1 in 307 women having bacterial vaginosis, which is a serious condition in the US affecting around 21 million women.
Positive DARE-BV1 study results demonstrate its potential in bacterial vaginosis
DARE-BV1 is the company’s experimental thermosetting bioadhesive hydrogel that contains 2% clindamycin phosphate designed as a one-time, convenient, vaginally-administered bacterial vaginosis treatment. The study met its primary endpoint showing that a single DARE-BV1 administration was superiors relative to placebos as a therapeutic intervention for women having bacterial vaginosis.
Sabrina Martucci Johnson, Dare Bioscience’s CEO said that based on the topline data, DARE-BV1 showed clinical cure rate values more than those of currently FDA-approved bacterial vaginosis treatments. Johnson added that the success of the third phase clinical study marks a huge milestone for the company. The CEO said that the company started last year with a commercial partnership for Ovaprene® with Bayern and ended the year with the successful completion of Phase 3 DARE-BV1 clinical trial supporting NDA for bacterial vaginosis treatment.
Johnson indicated that there is a large unmet medical need for an effective and convenient, vaginally-administered single-dose treatment for bacterial vaginosis. She added that they believe that DARE-BV1 will be a new frontline treatment alternative for bacterial vaginosis. The FDA granted DARE-BV1 Fast Track designation based on the topline results from the Phase 3 trial and the company is planning to file an NDA in H1 2021.
DARE-BV1 effective and well-tolerated
The Phase 3 clinical trial’s primary endpoint was a clinical cure for bacterial vaginosis which occurred between 21 and 30 days after subjects had received the drug. A single DARE-BV1 dose was superior to a placebo. Equally, DARE-BV1 was effective in four secondary efficacy assessments. The drug was well tolerated in the trial without any early discontinuations because of adverse events with only one serious adverse event reported in the placebo group. Around 15.3%patients reported study-related adverse events compares to 9.7% in placebo.