SAN DIEGO, March 10, 2020 (GLOBE NEWSWIRE) — Daré Bioscience, Inc.(NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis (BV) in women. DARE-BV1 was previously granted Qualified Infectious Disease Product (QIDP) designation for the treatment of BV in August 2019. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% being developed for one-time vaginal administration for the treatment of BV.
“BV is estimated to affect more than 20 million women in the United States and has been associated with pre-term birth and infertility. With clinical cure rates of current FDA-approved products in the range of 37-68% and a high rate of recurrence, this condition requires more innovative, effective medicines,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Our Fast Track Designation for DARE-BV1 underscores that BV is a serious infection for which current treatment options are inadequate and validates DARE-BV1’s potential to address this unmet medical need.”
BV is the most common cause of vaginitis worldwide.1 While there are a number of FDA-approved treatment options for women diagnosed with BV, most have relatively low clinical cure rates (37-68%), which may be one of the key drivers of recurrence rates. It is estimated that as many as 50% of women treated for BV will experience a recurrence within twelve months of their treatment.2 DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit that occurred 7 to 14 days after a single administration in an investigator-initiated proof of concept study.
Daré plans to initiate a Phase 3 clinical study of DARE-BV1 in approximately 220 women with an anticipated topline data readout by the end of 2020 to support the New Drug Application (NDA) submission. Based on discussions with the FDA, the Phase 3 study will include a placebo control and assess the primary endpoint of clinical cure of BV (defined as resolution of specified clinical signs and symptoms from baseline visit) at the test-of-cure visit to occur 21 to 30 days after enrollment in the study. If this single Phase 3 study and the nonclinical studies to be conducted in parallel with the Phase 3 study are successful, Daré intends to file the NDA following the completion of the Phase 3 study.
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 frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed. 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.
BV has been associated with serious health issues, including preterm births, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV infection) and other chronic health problems.3 It is estimated that BV is present in at least 15% of the sexually active population making it more common than urinary tract infections and many times more common than the Trichomonas vaginalis infection and vulvovaginal candidiasis.4
- Clinical Infectious Diseases 2007; 44:213–9; https://doi.org/10.1086/509577
- The Journal of Infectious Diseases 2006; 193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274
- Centers for Disease Control and Prevention, www.cdc.gov/std/bv/stats.htm; Onderdonk, A. et al. “The Human Microbiome during Bacterial Vaginosis,” Clinical Microbiology Reviews, April 2016 Volume 29 Number 2
- Clinical Infectious Diseases 2007; 44:220–1; https://doi.org/10.1086/509584
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 hormone-free, monthly contraceptive intravaginal ring whose U.S. commercial rights are under a license agreement with Bayer; 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 bio-identical 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), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company, and may also use social media to communicate important information about the company, its finances, product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website (https://darebioscience.gcs-web.com/) and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Daré’s website mentioned above.