- Dare Bioscience Inc DARE announced Topline Efficacy Results from its phase 1/2 study of DARE-HRT1.
- DARE-HRT1 is a novel investigational intravaginal ring (IVR) designed to deliver bioidentical 17β-estradiol and bioidentical progesterone continuously for 28 days as part of hormonal therapy (HT).
- HT treats vasomotor symptoms (VMS) and urogenital syndrome associated with menopause.
- DARE-HRT1 could potentially be the first FDA-approved product to offer vaginal delivery of combined bioidentical estradiol and progesterone hormonal therapy in a convenient monthly format.
- The levels of estradiol released from the lower and higher dose formulations of DARE-HRT1 assessed in the study achieved statistically significant improvement in VMS and urogenital symptoms of menopause, as well as vaginal pH and maturation index.
- The study treatment was well tolerated. Topline PK data from the study will be available later in Q4 2022.
- Post-clinical development, Daré intends to use the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to leverage the FDA’s 505(b)(2) pathway to seek marketing approval of DARE-HRT1. Getting HRT1 in the US
- Price promotion: DARE shares are up 4.21% to $0.93 on Monday’s latest check.
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