Daré Bioscience Announces Publication of DARE-BV1 Proof of Concept Study for the Treatment of Bacterial Vaginosis
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% 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
Bacterial vaginosis is the leading cause of vaginitis worldwide and is estimated to affect more than 21 million women in
“Current FDA-approved treatments for the treatment of bacterial vaginosis offer clinical cure rates ranging from 37 to 68%,” said
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
“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
Earlier this year, Daré announced that the
Fast Track designation is granted by the FDA for drugs that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for more frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support approval. The Fast Track program is intended to facilitate development and expedite review of a Fast Track drug so that an approved product can reach the market expeditiously.
QIDP designation is available under Title VIII of the Food and Drug Administration Safety and Innovation Act, titled Generating Antibiotic Incentives Now (GAIN), which creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The primary incentive is a five-year exclusivity extension added to any exclusivity for which a QIDP qualifies upon FDA approval.
The publication entitled “Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis” is currently available in the Latest Articles section on the journal’s website, or at
- Clinical Infectious Diseases 2007; 44:213–9; https://doi.org/10.1086/509577
Centers for Disease Control and Prevention, Bacterial Vaginosis (BV) Statistics, viewed at https://www.cdc.gov/std/bv/stats.htm
- Clinical Infectious Diseases 2007; 44:220–1;https://doi.org/10.1086/509584
- Onderdonk, A. et al. “The Human Microbiome during Bacterial Vaginosis,” Clinical Microbiology Reviews,
April 2016Volume 29 Number 2 The Journal of Infectious Diseases2006; 193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.
Daré’s clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose
Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com),
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, the potential of a single administration of DARE-BV1 to safely and effectively treat bacterial vaginosis, the potential for DARE-BV1 to demonstrate a higher clinical cure rate than current FDA-approved drug products and become a front-line treatment option for bacterial vaginosis, the timing of availability of topline results of the DARE-BVFREE study and submission of a new drug application for DARE-BV1, the potential for regulatory approval of DARE-BV1 based on a single, successful Phase 3 clinical study, namely the DARE-BVFREE study, and the significance of Fast Track and QIDP designations for the DARE-BV1 program. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré’s ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Daré; Daré’s ability to develop, obtain regulatory approval for, and commercialize its product candidates; the failure or delay in starting, conducting and completing clinical trials or obtaining
Investors on behalf of Daré
Source: Daré Bioscience, Inc.