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Shares of the thinly-traded, nano-cap penny stock Daré Bioscience Inc (NASDAQ: DARE) were trading higher Monday.
Daré, which focuses on women's health, said Monday that its BV1 — a thermosetting hydrogel containing clindamycin phosphate 2% — has been given the Qualified Infectious Disease Product, or QIDP, designation by the FDA for the treatment of bacterial vaginosis in women.
BVI is a viscous liquid which goes through solution-to-gel transition using the body temperature as a trigger, which facilitates easy direction of the product to the site of infection.
"Receiving QIDP designation for DARE-BV1 for the treatment of BV is validation that BV is a serious infection for which current treatment options are inadequate," Daré CEO Sabrina Martucci Johnson said in a statement.
Why It's Important
The clinical cure rates for currently approved products in bacterial vaginosis are about 37-39%, and the condition affects over 21 million among women ages 14-49, according to Daré.
The proof-of-concept study of BV1 showed an 86% clinical cure rate in the evaluable subjects at the test-of-cure visit after a single administration.
The QIDP designation is meant to incentivize development of antibacterial and antifungal drug products that treat serious or life-threatening infections.
The designation confers:
a five-year exclusivity extension, added to any exclusivity for which a QIDP qualifies upon FDA approval
The QIDP designation also makes the product candidate eligible for Fast Track designation and Priority Review
Daré said it plans to start a late-stage study of BVI in about 250 women in the fourth quarter of 2019.
The company said it believes the Phase 3 study, if successful, would be sufficient for approval of BV1 to treat bacterial vaginosis.
Daré shares were rising 2.67% to 77 cents at the time of publication Monday.
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