Business
Daré Bioscience Announces FDA Clearance of IND Application for DARE-BV1 for Bacterial Vaginosis to Commence Pivotal Phase 3 Clinical Study
DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit (Day 7-14) after a single administration in an
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit (Day 7-14) after a single administration in an investigator-initiated proof of concept study\nSAN DIEGO, Dec. 18, 2019 (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 cleared its investigational new drug (IND) application for DARE-BV1, its novel thermosetting bioadhesive hydrogel containing 2% clindamycin phosphate being developed for one-time vaginal administration for the treatment of bacterial vaginosis (BV), a common but difficult to treat vaginal infection estimated to affect more than 20 million women in the United States.1\n With the IND clearance from the FDA, Daré can commence the planned Phase 3 clinical study of DARE-BV1 in approximately 220 women in 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, or the Day 21-30 visit. If this single Phase 3 study and the nonclinical studies that Daré plans to conduct in parallel with the Phase 3 study are successful, Daré intends to file the NDA following the completion of this Phase 3 study. “With the potential to demonstrate a higher clinical cure rate than the current FDA-approved vaginally-administered treatments and its single application one-and-done dosing regimen, DARE-BV1 could disrupt the bacterial vaginosis market. This announcement marks another important milestone for Daré, becoming the third program in our portfolio where we have achieved a meaningful clinical or regulatory objective this quarter,” said Sabrina Martucci Johnson, President & CEO of Daré Bioscience. “Earlier in the quarter, we announced the successful completion of a clinical study of Ovaprene, supporting its potential to be the first hormone-free, monthly contraceptive option for women and continued development toward premarket approval pending the successful commencement and completion of a pivotal contraceptive effectiveness and safety trial. More recently, we announced the conclusi...