A first-in-class product for the clearance of high-risk human papillomaviruses

SUMMARY Daré Bioscience is developing DARE-HPV, an innovative anti-viral vaginal insert to address the health threat posed by persistent high-risk human papillomaviruses (HR-HPV) infections, which are associated with cervical cancers. With a lack of FDA-approved treatments for persistent HR-HPV infections, this novel therapy combines two antiretroviral drugs, lopinavir and ritonavir, targeting the viral lifecycle and restoring normal cellular growth. A clinical proof-of-concept study showed promising results, with a significant proportion of women experiencing HR-HPV viral clearance 12 weeks after a 14-day treatment. The proposed SBIR Phase II studies are focused on achieving three main objectives to ensure DARE-HPV’s safety before submitting an IND application. First, they aim to optimize and validate analytical assays for measuring the active pharmaceutical ingredients presence in both blood and cervical samples. Second, they will conduct comprehensive intravaginal safety and toxicity studies in a relevant biological model, female sheep. These studies are designed to confirm the absence of clinical pathology and define the pharmacokinetic parameters in the blood and cervical tissue after administration. Third, they will evaluate the potential for DARE-HPV dermal hypersensitivity and evaluate the impact of DARE-HPV on condom integrity. Upon successful completion of these studies, Daré Bioscience intends to file for IND status using the 505(b)(2) pathway, with Kaletra® as the reference drug.