Dare Bioscience announces publication of data from Phase 1/2 trial of DARE-HRT1

Dare Bioscience 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 designed to release bio-identical 17beta2-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen, is part of Dare’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 study enrolled a total of 21 subjects, who were randomized to receive one of two versions of DARE-HRT1, either IVR1 or IVR2, and used DARE-HRT1 over 12 weeks. 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. “The clinical and quality of life issues associated with menopause continue to take center stage as women and healthcare providers increasingly appreciate the need for more treatment options. We are excited to have the results of our Phase 1/2 study published in this prestigious peer-reviewed journal and we believe the study results underscore DARE-HRT1’s compelling therapeutic value proposition and its potential to be a first-in-category non-oral and convenient non-daily option for women suffering from vasomotor symptoms associated with menopause, such as hot flashes and night sweats,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “Guidance from the North American Menopause Socierty asserts that hormone therapy remains the most effective treatment for vasomotor symptoms. Non-oral hormone therapy, including transdermal and vaginal routes of administration, may offer potential advantages compared with oral hormone therapy because non-oral routes bypass the first-pass hepatic effect. We look forward to continuing our preparation for the planned Phase 3 study and to providing updates on our progress.”