Dare Bioscience's DARE-HPV Receives FDA Approval for Phase 2 Trials

Dare Bioscience announced that the U.S. Food and Drug Administration, FDA, has cleared the Company's Investigational New Drug, IND, application for DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, allowing initiation of a planned Phase 2 clinical study to evaluate DARE-HPV as a potential treatment for persistent high-risk human papillomavirus infection. "FDA clearance to proceed to Phase 2 represents an important regulatory milestone for DARE-HPV and for women who currently have no treatment options for persistent high-risk HPV infection," said Sabrina Johnson, President and CEO of Dare Bioscience. "For decades, women have been told to 'watch and wait' to see if the virus clears on its own. If it does not, the only option has been surgery once precancerous changes appear. DARE-HPV is designed to intervene earlier - targeting the virus itself before progression to cervical disease - aiming to eliminate the frequent "watchful waiting" visits to a health care provider that are costly, burdensome, and contribute to socioeconomic and racial disparities in cervical cancer."