Dare Bioscience Inc (NASDAQ: DARE) announced encouraging topline consequences from its Phase 1 scientific pilot of DARE-HRT1. DARE-HRT1 is a novel IVR intended to transport bio-identical 17β-estradiol and bio-identical progesterone unceasingly over 28 days.
Consequences Support Latent as the First Cyclic Treatment for both the Vasomotor and the Vaginal Indications of Menopause
The topline statistics from the study support DARE-HRT1’s latent to be the first FDA-approved product to bid vaginal distribution of blend bio-identical estradiol and bio-identical progesterone hormone treatment in a suitable monthly arrangement to treat both VMS as well as vaginal symptoms of menopause.
“DARE-HRT1 established the capability to transport two different active pharmaceutical constituents, in this circumstance two bio-identical hormones, consistently over a 28-day period. Producing encouraging topline data in our first Phase 1 study exploiting our fresh IVR know-how signifies an imperative medical attainment for Daré and for the IVR platform,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “For some womenfolk, hormone treatment is a highly operative usage for the indications related with menopause, such as hot sparks and vaginal aridness, and may also avert bone loss and breakage.”
Dr. Robert Langer established the IVR know-how used in DARE-HRT1 from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School.
DARE-HRT1 Phase 1 Scientific Pilot Study Scheme
The randomized, open-label, three-arm, corresponding collection Phase 1 training was intended to assess the pharmacokinetics (PK) of DARE-HRT1 in about 30 healthy, post-menopausal females with intact uteri. The study’s main goal was to define the PK strictures of two different dose mixtures over 28 days. Ancillary purposes of the study were to evaluate the security and acceptability of DARE-HRT1 and to liken the systemic experience of estradiol of DARE-HRT1 over 28 days against an everyday mixture of FDA-approved oral estrogen. Oral progesterone produces assessed in the Phase 1 study.
Daré ideas to submit statistics from the Phase 1 scientific study of DARE-HRT1 for publication in a peer-reviewed journal.