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Shares of the thinly-traded, nano-cap penny stock Daré Bioscience Inc (NASDAQ:DARE) were trading higher Monday.
What Happened
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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.
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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
What's Next
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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Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.