Benzinga | Aug 20, 2020 08:02AM EDT

Dar Bioscience Announces Publication Of DARE-BV1 Proof Of Concept Study For The Treatment Of Bacterial Vaginosis

SAN DIEGO, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Dar? Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced the publication of a proof of concept study of DARE-BV1 in Clinical and Experimental Obstetrics & Gynecology, an international journal focused on publication of high quality scientific research related to obstetrics and gynecology and women's health. 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% 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 David Friend, PhD, Chief Scientific Officer of Dar? Bioscience. "At the test-of-cure visit 7 to 14 days after dosing, 86% of the evaluable patients in the study were clinically cured of their bacterial vaginosis and 96% 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.1,2 It is estimated that bacterial vaginosis is present in at least 15% of the sexually active population3 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.2,4

"Current FDA-approved treatments for the treatment of bacterial vaginosis offer clinical cure rates ranging from 37 to 68%," said Sabrina Martucci Johnson, President and Chief Executive Officer of Dar? Bioscience. "Alarmingly, as many as 50% 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." 5

Dar? 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 Ms. 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."

Earlier this year, Dar? announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis, in addition to receiving Qualified Infectious Disease Product (QIDP) designation for the treatment of bacterial vaginosis in August of 2019.

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

https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.04.5304.

2 Clinical Infectious Diseases 2007; 44:213--9; https://doi.org/10.1086/509577

4 Centers for Disease Control and Prevention, Bacterial Vaginosis (BV) Statistics, viewed at https://www.cdc.gov/std/bv/stats.htm

6 Clinical Infectious Diseases 2007; 44:220--1; https://doi.org/10.1086/509584

8 Onderdonk, A. et al. "The Human Microbiome during Bacterial Vaginosis," Clinical Microbiology Reviews, April 2016 Volume 29 Number 2

10 The Journal of Infectious Diseases 2006; 193:1478--86; https://www.ncbi.nlm.nih.gov/pubmed/16652274