Daré Bioscience Announces Publication in The Journal of The North American Menopause Society of Positive Efficacy Findings for the Treatment of Menopausal Symptoms from a Phase 1/2 Clinical Trial of DARE-HRT1 Intravaginal Rings

• DARE-HRT1 Demonstrated Preliminary Treatment Efficacy for Both Vasomotor Symptoms (VMS) and Genitourinary Syndrome of Menopause (GSM)

• The North American Menopause Society (NAMS) Guidance on Hormone Therapy States that Dosing Estrogen and Progestogen in Combination May Offer Important Benefits to Women, and NAMS Observed that Non-Oral Routes of Administration May offer Advantages Over Orally Administered Therapies

• Daré Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of 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, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of positive preliminary efficacy results from its Phase 1/2 clinical study of DARE-HRT1 in healthy postmenopausal women. DARE-HRT1, an investigational ethylene vinyl acetate copolymer intravaginal ring (IVR) designed to release bio-identical 17β2-estradiol and progesterone over 28 days 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. DARE-HRT1 is being developed for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri.

The journal article, titled “A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability 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 9 of Menopause. The article reports the results of the exploratory objectives of the Phase 1/2 study, which included assessing the usability, acceptability and preliminary efficacy of two dose configurations of DARE-HRT1. The results of the primary objectives of the study, which were to evaluate the safety and pharmacokinetics (PK) of the two dose configurations of DARE-HRT1, are described in a separate article published in an earlier issue of Menopause..