Dare Bioscience announces PK results from DATE HRT1 Phase 1/2 study

Dare Bioscience announced topline pharmacokinetic, PK, results from its Phase 1 / 2 clinical trial of DARE-HRT1 that support the potential of DARE-HRT1 as an effective hormone therapy, HT, based on the levels of hormones released. DARE-HRT1 is a novel, investigational intravaginal ring, IVR, designed to deliver bio-identical 17beta-estradiol and bio-identical progesterone continuously over a 28-day period as part of a HT regimen. 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 hormone therapy in a convenient monthly format. Dare 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. "The delivery of hormone therapy over a 12-week study via a 28-day intravaginal ring which requires no daily intervention supports DARE-HRT1’s potential to be a first-in-category option, offering ease-of-use and consistent dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks," said Dr. Annie Thurman, Medical Director of Dare Bioscience. "We believe these Phase 1 / 2 topline data support progressing directly into a single Phase 3 study following the Investigational New Drug submission to and clearance from the FDA."