Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy
Daré Bioscience, Inc. recently announced the initiation of a Phase 1 clinical trial of DARE-HRT1, designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period and is being developed as a potential new option for hormone therapy (HT) for the treatment of vasomotor symptoms, commonly called hot-flashes, and the genitourinary syndrome of menopause to prevent bone loss and fracture associated with menopause. The North American Menopause Society (NAMS) hormone therapy position statement supports the use of HT in peri- and post-menopausal women, recommends administering both estrogen to reduce symptoms and progesterone to prevent thickening of the uterine wall and observes that non-oral routes of administration may offer advantages over orally administered therapies. DARE-HRT1 has the potential to be the first FDA-approved intravaginal ring (IVR) product to meet these NAMS guidelines.
“We believe this study will provide important scientific information for both DARE-HRT1 and DARE-FRT1, two of our development-stage programs, given that they both utilize the same IVR technology and bio-identical progesterone as an active ingredient,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “Specifically, this Phase 1 study of DARE-HRT1 will evaluate the ability of DARE-HRT1 to achieve its target dual- release objectives, as well as the ability of the IVR technology to release two different active drugs at two different rates. In addition, we anticipate collecting useful pharmacokinetics characteristics of the bio-identical progesterone alone, which can be expected to directly apply to DARE-FRT1, a bio-identical progesterone-only IVR being developed for luteal phase support as part of an invitro fertilization regimen and as a more convenient treatment option for prevention of pre-term birth.”
The randomized Phase 1 study will evaluate the pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal women. The primary objective of the study is to describe the PK parameters over 28 days of two different dose combinations of DARE-HRT1. Secondary endpoints of the study include assessing the safety and tolerability of DARE-HRT1 and comparing the exposure of estradiol, estrone, and progesterone of DARE-HRT1 over 28 days against a daily combination of oral estrogen (Estrofem) and oral progesterone (Prometrium).
The Phase 1 study of DARE-HRT1 is being conducted by Daré’s wholly owned Australian subsidiary at specialty women’s health sites in Australia. Currently, Australia’s research and development tax incentive (R&DTI) gives 43.5% of every dollar spent by eligible companies on eligible R&D activities back to those companies in a cash payment. At the conclusion of the Phase 1 study, Daré’s subsidiary intends to apply for the maximum refundable cash credit then available under the Australian R&DTI program for eligible study costs incurred.
“At Daré, we have a deep passion and commitment for transforming science into solutions for women,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The polymer-based segmented IVR delivery platform developed by renowned scientists Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School is a truly innovative technology designed specifically for women to avoid first-pass metabolic effects commonly seen with oral medications and to offer potentially more convenient approaches for sustained delivery of one or more active drugs at variable doses and convenient durations, including a once-a-month option. The potential cost savings afforded by the Australian R&D tax incentive program provides an opportunity to advance potential first-in-category product candidates like DARE-HRT1 and DARE-FRT1 capital efficiently.”
Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility. Daré’s clinical-stage product candidates include potential first-in-category candidates in clinical development: Ovaprene, a hormone-free, monthly contraceptive intravaginal ring whose US commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. For more information,visit www.darebioscience.com.
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