Press Release
Daré Announces Presentation of Positive Clinical Findings for Vaginal Administration of Novel Formulation of Clindamycin Phosphate for the Treatment of Bacterial Vaginosis at the 2019 Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology
“In the study, DARE-BV1 achieved a clinical cure rate of 86% at the test-of-cure endpoint, well above currently
BV is the most common vaginal infection in women ages 15-44.1 BV is characterized by a shift in the vaginal flora from the dominant Lactobacillus to a polymicrobial flora.2 BV has been associated with serious health issues, including preterm births, infertility, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV infection) and other chronic health problems.1,2
DARE-BV1 features a novel thermosetting hydrogel delivery technology that is easy to apply, highly viscous and may have better bio-adhesion when compared to commonly prescribed creams and gels used to treat BV. It is believed that these unique formulation characteristics result in better antibiotic delivery to the vaginal infection leading to higher clinical cure rates and better clinical outcomes. Daré intends to start a single Phase 3 registrational trial of DARE-BV1 later this year.
The poster will be presented by Dr. Friend.
Presentation details are below. The poster will also be made available on the Events and Presentations page of Daré’s investor relations website (http://ir.darebioscience.com).
Title:
Proof of Concept Study to Evaluate the Efficacy of a Novel Thermosetting Bioadhesive 2% Clindamycin Phosphate Vaginal Gel in the Treatment Bacterial Vaginosis
Dates & Times:
1.
2. Onderdonk, A. et al. “The Human Microbiome during Bacterial Vaginosis,” Clinical Microbiology Reviews,
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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bioidentical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com),
Forward-Looking Statements
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, statements relating to the potential of DARE-BV1 to treat bacterial vaginosis, the timing of Daré’s Phase 3 clinical study of DARE-BV1 and the potential for regulatory approval of DARE-BV1 based on a single, successful Phase 3 clinical study. 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; 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
Contacts:
Investors on behalf of Daré
Burns McClellan
lroth@burnsmc.com
212.213.0006
OR
Media on behalf of Daré
Canale Communications
jake@canalecomm.com
619.849.5383
Source: Daré Bioscience
Source: Dare Bioscience, Inc.