The EVMS Clinical Research Center worked with Daré Bioscience, Inc., a leader in women’s health innovation, on a clinical trial that produced positive results for women diagnosed with bacterial vaginosis.
The DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluated DARE-BV1 in 307 women diagnosed with bacterial vaginosis (BV), a serious condition estimated to affect approximately 21 million women in the United States.
“Bacterial vaginosis is the most common cause of vaginal discharge worldwide and has been linked to several adverse women’s health outcomes including pre-term delivery and HIV acquisition,” says Andrea Thurman, MD, Professor of Obstetrics and Gynecology and principal investigator. “We were honored to participate in this study and are excited about the high cure rates found with this one dose topical treatment.”
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.
“Based on these topline results, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products for the treatment of bacterial vaginosis,” says Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We believe there is a large unmet need for a more efficacious and convenient, single-dose vaginally administered product to treat bacterial vaginosis, and we believe DARE-BV1 could become a new front-line treatment option.”
DARE-BV1 received Fast Track designation from the FDA earlier this year and, based on the topline results of this trial, the company plans to file an NDA in the first half of 2021.