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Daré Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1/2 Open-Label Safety and Pharmacokinetics Study of DARE-HRT1 in Healthy Postmenopausal Women
Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of Vasomotor Symptoms (VMS) due to Menopause DARE-HRT1 has the potential to
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of Vasomotor Symptoms (VMS) due to Menopause DARE-HRT1 has the potential to be the first FDA-approved monthly intravaginal ring delivering both estrogen and progestogen hormone therapy SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today 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 17β2-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 b...