SAN DIEGO—Mid-August saw Daré Bioscience Inc. announce the publication of a proof-of-concept study of DARE-BV1 in the journal Clinical and Experimental Obstetrics & Gynecology. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% that is being evaluated as a one-time vaginally administered treatment for bacterial vaginosis (BV).
The publication, entitled “Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis,” reported that a single dose of the study drug, now known as DARE-BV1, administered to 30 patients diagnosed with bacterial vaginosis showed a meaningful clinical cure rate of 86 percent in evaluable patients at the test-of cure visit. Clinical cure was defined as the resolution of specified clinical signs and symptoms of bacterial vaginosis that were present at the time of enrollment in the study.
“This proof of concept study suggests that DARE-BV1 has the potential to be a highly effective treatment option for bacterial vaginosis, the most common cause of vaginal symptoms among women,” said Dr. David Friend, chief scientific officer of Daré Bioscience. “At the test-of-cure visit 7 to 14 days after dosing, 86 percent of the evaluable patients in the study were clinically cured of their bacterial vaginosis and 96 percent of those women remained clinically cured at the follow-up visit 21 to 30 days after dosing. There were no reports of adverse reactions to DARE-BV1 over the duration of the study.”
Bacterial vaginosis is the leading cause of vaginitis worldwide and is estimated to affect more than 21 million women in the United States. It is estimated that bacterial vaginosis is present in at least 15 percent of the sexually active population and is associated with a variety of serious health issues including preterm birth, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV) and other chronic health problems.
“Current FDA-approved treatments for the treatment of bacterial vaginosis offer clinical cure rates ranging from 37 to 68 percent,” said Sabrina Martucci Johnson, president and CEO of Daré Bioscience. “Alarmingly, as many as 50 percent of women treated for bacterial vaginosis will experience a recurrence within 12 months of treatment, which underscores the need for more effective treatment options for women.”
Daré recently announced the initiation of the DARE-BVFREE study, a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study of DARE-BV1 for the treatment of bacterial vaginosis. The DARE-BVFREE study is expected to enroll approximately 240 participants, ages 12 and older, diagnosed with bacterial vaginosis across multiple clinical sites in the United States. The primary endpoint is clinical cure of bacterial vaginosis, defined as resolution of specified clinical signs and symptoms, at the test-of-cure visit to occur 21 to 30 days after enrollment in the study.
“If DARE-BV1 delivers a similarly high clinical cure rate in the Phase 3 pivotal study as it did in the pilot study, we believe DARE-BV1 could become a new front-line treatment option for women diagnosed with bacterial vaginosis,” said Johnson. “Given the anticipated short duration of the Phase 3 study, we expect to report topline data from the study by year-end 2020. Positive results from this single pivotal study will enable us to submit a new drug application for DARE-BV1 with the FDA in early 2021, two years from licensing the technology.”
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