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.
The planned Phase 2 study is expected to evaluate the safety and antiviral activity of DARE-HPV in women with persistent high-risk HPV infection. The program, including the planned Phase 2 clinical trial, is supported by a $10 million contract funded by the Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services, $6.5 million of which has been received to date.
Persistent high-risk HPV infection represents a substantial unmet medical need:
“This program reflects our commitment to advancing science where women have historically had limited or no therapeutic options,” Johnson added. “With ARPA-H support and FDA clearance in hand, we are positioned to advance DARE-HPV efficiently into Phase 2 and generate clinical data that could meaningfully change how persistent high-risk HPV infection is managed.”
Daré Bioscience will provide additional details regarding the Phase 2 study design and anticipated timelines for study initiation, which the company is preparing for 2026, in the coming months.
About Daré Bioscience
Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.
To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit http://www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.
Contacts:
Daré Bioscience Investor Relations
[email protected]
Source: Daré Bioscience, Inc.
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