Daré Bioscience receives new U.S. patent for HPV treatment program

Daré Bioscience (NASDAQ: DARE) announced the issuance of U.S. Patent No. 12,678,439, covering pharmaceutical compositions of lopinavir and ritonavir formulated for topical application in the treatment of HPV-related cervical pathologies, according to a company press release.

The patent was issued by the United States Patent and Trademark Office on July 14, 2026, to Douglas Pharmaceuticals Limited, which licenses the technology to Daré Bioscience. The patent includes claims for compositions designed to treat or inhibit early-stage neoplasias and to treat or prevent HPV-related cervical neoplasias. Protection is expected to extend into at least 2039. Daré holds an exclusive U.S. license to the patent and the broader related patent family under a 2023 agreement with Douglas Pharmaceuticals.

The patent supports Daré Bioscience's DARE-HPV program, an investigational fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert. The company is developing the product as a non-surgical, self-administered treatment for persistent high-risk HPV infection. There are currently no FDA-approved pharmacologic treatments for HPV infection.

DARE-HPV is currently being evaluated in a Phase 2 randomized, placebo-controlled, double-blind clinical study enrolling approximately 100 women with confirmed persistent high-risk HPV infection. The study's primary endpoint is HPV clearance at three months post-treatment. Topline results are expected in 2027.

The program is supported by approximately $10 million in non-dilutive funding from the Advanced Research Projects Agency for Health (ARPA-H) and a $2.0 million award from the National Institute of Allergy and Infectious Diseases (NIAID), Award Number R44AI188623.

Sabrina Martucci Johnson, President and CEO of Daré Bioscience, stated: "Millions of women experience high-risk HPV infection each year in the United States, yet there is still no FDA-approved pharmacologic treatment to clear the infection."

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