Daré Bioscience, Inc., a leader in women’s health innovation, today announced that data from the DARE-BVFREE Phase 3 study of DARE-BV1, a thermosetting vaginal gel for the treatment of bacterial vaginosis, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 - May 2, 2021.
The poster presentation will highlight the positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating Daré’s product candidate DARE-BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health risks and very disruptive symptoms and is 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 one-time vaginally administered treatment for bacterial vaginosis. The results from the DARE-BVFREE study demonstrate DARE-BV1’s potential to provide improved clinical cure rates as compared to those of the current branded vaginal and oral prescription products for bacterial vaginosis.
DARE-BVFREE randomized 307 women diagnosed with bacterial vaginosis at 32 centers across the United States in a 2:1 ratio to receive a single vaginal dose of DARE-BV1 or a single vaginal dose of placebo gel to be applied intravaginally within one day of randomization. Patients were evaluated during three clinic visits: Day 1 (screening and randomization visit), Day 7-14 (assessment visit), and Day 21-30 (test-of-cure visit). The study met its primary endpoint, demonstrating that as a primary therapeutic intervention a single vaginal dose of DARE-BV1 was statistically superior to placebo at Day 21-30 in the modified intent-to-treat (mITT) population (70% compared to 36% of subjects clinically cured). Additionally, DARE-BV1 demonstrated clinical cure rates of 77% at Day 21-30 and 81% at Day 7-14 in the per protocol population, compared to 43% and 30% for placebo cream, respectively. DARE-BV1 was well-tolerated in the study, and there were no early discontinuations due to adverse events.
“As a practicing physician focused on women’s sexual and vaginal health, I welcome new treatment options for women suffering from bacterial vaginosis, a condition that has serious and deleterious consequences if not adequately addressed,” said Andrew T. Goldstein, MD, FACOG, Medical Advisor of Daré Bioscience. “In the DARE-BVFREE trial, DARE-BV1 was well-tolerated and demonstrated clinical cure efficacy rates superior to those shown by current branded prescription products for the treatment of bacterial vaginosis. The DARE-BVFREE trial followed the stringent enrollment criteria of the new 2019 FDA guidance document for developing drugs to treat bacterial vaginosis, and featured a patient population that we believe is very representative, including a large proportion of women, about 75%, who reported one or more episodes of bacterial vaginosis in the 12 months before they were randomized into the study.”
In DARE-BVFREE, the clinical cure was defined as resolution of the specific clinical signs that comprise the Amsel criteria; specifically, resolution of abnormal vaginal discharge associated with bacterial vaginosis, clue cells less than 20% of total epithelial cells on microscopy, and a negative 10% KOH “whiff” test. DARE-BV1 demonstrated clinical cure rates of 70% at Day 21-30 (primary endpoint) and 76% at Day 7-14 in the mITT population, compared to 36% and 24% for placebo cream, respectively, and rates of 77% at Day 21-30 and 81% at Day 7-14 in the per-protocol population, compared to 43% and 30% for placebo cream, respectively. Consistent with the 2019 FDA guidance document, the mITT study population (N=180) excludes subjects from the intent-to-treat (ITT) population (N=307) who subsequently demonstrated a positive test result for other concomitant vaginal or cervical infections at baseline, or who have a baseline Nugent score of less than 7 (a score of 7 or greater represents bacterial vaginosis). The per-protocol population (N=148) means subjects from the mITT population who have no major protocol violations that impact the primary or secondary endpoints or who received any other bacterial vaginosis therapy for any reason.
“Studies have shown recurrence rates of up to 60% within 12 months of treatment for bacterial vaginosis, and currently marketed FDA-approved products for the treatment of bacterial vaginosis have clinical cure rates in the mid-30% to the high-60% range,” said David Friend, Ph.D., Chief Scientific Officer of Daré Bioscience. “Based on the topline results of the DARE-BVFREE study, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products. If approved, we believe DARE-BV1 will be an important new and convenient one-time vaginally-administered treatment option with the potential to improve clinical outcomes and overall quality of life for women suffering with bacterial vaginosis.”
The ePoster entitled Phase 3 Study of a Single-Dose Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis, authored by Steven Chavoustie, MD, Andrew Goldstein, MD, Judy Gendreau, MD, Christine Mauck, MD, MPH, David Friend, Ph.D., and Sharon Hillier, Ph.D., will be presented virtually by Steven Chavoustie, MD and will be available to meeting attendees on the ACOG website at https://www.acog.org, beginning April 30, 2021.