Benzinga | Dec 7, 2020 08:04AM EST

Dar Bioscience Announces Topline Results From DARE-BVFREE Phase 3 Trial Of DARE-BV1 In Patients Diagnosed With Bacterial Vaginosis; DARE-BV1 Met Primary Endpoint And All Pre-specified Secondary Efficacy Endpoints

DARE-BV1 met the primary endpoint of the study and all pre-specified secondary efficacy endpoints; demonstrated significantly greater clinical cure rates compared to placebo



DARE-BV1 has Fast Track and QIDP designations from FDA

New drug application (NDA) submission planned 1H of 2021

SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Dar? Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with bacterial vaginosis, a serious condition estimated to affect approximately 21 million women in the United States. DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a convenient, one-time vaginally-administered treatment for bacterial vaginosis. The trial met its primary endpoint demonstrating that a single administration of DARE-BV1 was superior to placebo as a primary therapeutic intervention for women diagnosed with bacterial vaginosis.