Daré Bioscience IncDARE announced topline efficacy results from its Phase 1/2 trial of DARE-HRT1.
DARE-HRT1 is a novel, investigational intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over 28 days as part of a hormone therapy (HT) regimen.
HT treats vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause.
DARE-HRT1 can potentially be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and progesterone hormone therapy in a convenient monthly format.
Estradiol levels released from the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS and the genitourinary symptoms of menopause and vaginal pH and maturation index.
The study treatment was well tolerated. The topline PK data from the study will be available later in Q4 of 2022.
Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol, and progesterone, to utilize FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
Price Action: DARE shares are up 4.21% at $0.93 on the last check Monday.
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