{"id":963940,"date":"2026-05-18T08:06:59","date_gmt":"2026-05-18T12:06:59","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-initiates-phase-2-study-of-dare-hpv-a-novel-pharmacologic-treatment-for-persistent-high-risk-hpv-infection-with-no-fda-approved-therapies\/"},"modified":"2026-05-18T08:06:59","modified_gmt":"2026-05-18T12:06:59","slug":"dare-bioscience-initiates-phase-2-study-of-dare-hpv-a-novel-pharmacologic-treatment-for-persistent-high-risk-hpv-infection-with-no-fda-approved-therapies","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-initiates-phase-2-study-of-dare-hpv-a-novel-pharmacologic-treatment-for-persistent-high-risk-hpv-infection-with-no-fda-approved-therapies\/","title":{"rendered":"Dar\u00e9 Bioscience Initiates Phase 2 Study of DARE-HPV, a Novel Pharmacologic Treatment for Persistent High-Risk HPV Infection with No FDA-Approved Therapies"},"content":{"rendered":"
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Each year, an estimated six million women in the United States acquire a high-risk HPV infection \u2014 and there are no FDA-approved treatments<\/p>\n

DARE-HPV development is backed by a $10 million U.S. government (ARPA-H)-funded contract; topline data readout expected in 2027<\/p>\n

SAN DIEGO, May 18, 2026 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE),<\/strong> a purpose-driven health biotech company solely focused on closing the gap in women\u2019s health between promising science and real-world solutions, today announced the initiation of its Phase 2 clinical study of DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, designed to evaluate DARE-HPV as a potential treatment for persistent high-risk human papillomavirus (HPV) infection.<\/p>\n

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<\/strong> for HPV infection.<\/p>\n

The Phase 2 study is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and antiviral activity of a lower and higher DARE-HPV dose compared with placebo in approximately 100 women with confirmed persistent high-risk HPV infection over an up to 21-day course of daily treatment. The primary endpoint is HPV clearance rate at three months post treatment. Secondary endpoints include safety, tolerability, and reduction in viral load. Dar\u00e9 Bioscience expects to report topline data in 2027. Study initiation follows clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for the study, announced in February 2026, and represents a significant clinical development milestone.<\/p>\n

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. If approved, DARE-HPV could be the first FDA-approved pharmacologic treatment for HPV infection<\/strong>, addressing a substantial unmet need, with more than 6 million women per year in the United States estimated to acquire a high-risk HPV infection.<\/p>\n

\u201cInitiating this Phase 2 study marks a historic step \u2014 for the first time, women with persistent high-risk HPV infection may have access to this pharmacologic treatment as part of a clinical trial,” said Sabrina Johnson, President and CEO of Dar\u00e9 Bioscience. \u201cFor decades, women have been told to \u2018watch and wait\u2019 to see if the virus clears on its own or the infection progresses to precancerous lesions on the cervix. DARE-HPV is designed to intervene earlier \u2013 targeting the virus itself before progression to cervical disease \u2013 aiming to eliminate the frequent \u2018watchful waiting\u2019 visits to a health care provider that are costly, burdensome, and contribute to socioeconomic and racial disparities in cervical cancer. We are grateful to ARPA-H, our clinical investigators, and most importantly, to the women who will participate in this study.\u201d<\/p>\n

HPV is one of the most common sexually transmitted viral infections worldwide. An estimated over 11 million women in the U.S. alone acquire a new HPV infection every year. While most HPV infections resolve spontaneously, an estimated 6 million of those women per year experience \u201chigh-risk\u201d HPV infection, or an HPV infection caused by one of the carcinogenic HPV types, that can progress to precancerous cervical lesions and, ultimately, cervical cancer if left untreated. According to the Centers for Disease Control and Prevention, high-risk HPV types are responsible for nearly all cases of cervical cancer in the United States. Persistent high-risk HPV infection refers to testing positive for a high-risk HPV type at consecutive timepoints for at least 12 months.<\/p>\n

Today, the standard of care does not treat the virus. Instead, women with high-risk HPV infection are monitored through repeated screening. Intervention typically occurs only after precancerous lesions develop, often requiring surgical procedures such as excisional or ablative treatments of cervical tissue. These procedures may increase the risk of preterm birth in future pregnancies and can pose risks to fertility \u2013 creating a significant physical and emotional burden for women.<\/p>\n

Persistent high-risk HPV infection represents a substantial unmet medical need:<\/p>\n