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

Dare Bioscience announced the publication of positive preliminary efficacy results from its Phase 1/2 clinical study of DARE-HRT1 in healthy postmenopausal women. The journal article, titled “A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability of DARE-HRT1 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 Dare’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 of the two dose configurations of DARE-HRT1, are described in a separate article published in an earlier issue of Menopause. “Data from this study support further development of DARE-HRT1 as a potential first-in-category product to offer bio-identical estradiol and bio-identical progesterone therapy in a convenient monthly, non-oral format, consistent with NAMS guidance for delivering both hormones, together,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “We look forward to advancing DARE-HRT1 into a single Phase 3 pivotal clinical trial to support a new drug application for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri.”