Daré Bioscience, Inc. announced the publication in Menopause: The Journal of The North American Menopause Society of data from a Phase 1/2 clinical trial that evaluated the safety and pharmacokinetics of DARE-HRT1. DARE-HRT1, an investigational intravaginal ring (IVR) designed to release bio-identical 17ß2-estradiol (E2) and bio-identical progesterone (P4) continuously over a 28-day period as part of a hormone therapy regimen, is part of Daré’s proprietary IVR technology platform originally developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. The article, titled “A phase 1/2, open-label, parallel group study to evaluate the safety and pharmacokinetics of DARE-HRT1 (80 µg estradiol/4 mg progesterone and 160 µg estradiol/8 mg progesterone intravaginal rings) over 12 weeks in healthy postmenopausal women,” is available online through both the Latest Articles section of the Menopause journal’s website, as well as the Scientific & Clinical Publications section of Daré’s website, and will be published in Volume 30, Issue 8 of Menopause.

The study enrolled a total of 21 subjects, who were randomized (1:1) to receive one of two versions of DARE-HRT1, either IVR1 (E2 80 µg/d with P4 4 mg/d) or IVR2 (E2 160 µg/d with P4 8 mg/d), and used DARE-HRT1 over 12 weeks (three 28-day cycles). The study results demonstrated both versions of DARE-HRT1 were safe and released E2 in systemic concentrations in the low, normal premenopausal range and P4 in systemic concentrations predictive of endometrial protection. Data from the study support continued clinical development of DARE-HRT1 for the treatment of menopausal symptoms. Daré previously reported positive topline data from the Phase 1/2 study of DARE-HRT1 in January 2023 and October 2022.

DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone therapy in a convenient monthly format. Daré plans to advance DARE-HRT1 into a single Phase 3 clinical trial to support a new drug application for DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri. DARE-HRT1 505(b)(2) Regulatory Pathway: Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S. Daré intends to seek FDA approval of DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri.

Based on pre-IND communications with the FDA and the topline PK data from the DARE-HRT1 Phase 1 /2 study, Daré believes FDA approval of DARE-HRT1 for that indication is achievable via the 505(b)(2) pathway supported by a single, placebo-controlled, Phase 3 clinical trial of DARE-HRT1 and a scientifically justified PK “bridge” (via a relative bioavailability trial) between DARE-HRT1 and the selected listed estradiol and progesterone drugs. Ongoing activities to support progressing directly into a single Phase 3 study to support registration include manufacturing and non-clinical studies to support the IND submission and the planned IND-opening Phase 3 study.