Daré Bioscience Announces FDA Clears Its Investigational New Drug Application For DARE-HPV To Initiate Planned Phase 2 Clinical Study For Papillomavirus Infection Treatment

Daré Bioscience, Inc. (NASDAQ:DARE), a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions, today 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 (HPV) infection.

DARE-HPV is being developed as a non-surgical, localized, self-administered therapy designed to clear persistent high-risk HPV infection. HPV infection is the underlying cause of 99% of cervical cancer cases in the United States. There are currently no FDA-approved pharmacologic treatments for HPV infection.

By targeting the virus itself rather than waiting for cellular changes to develop, DARE-HPV has the potential to redefine the treatment paradigm in cervical disease prevention.