Daré Bioscience Initiates Phase 1/2 Clinical Study of DARE-HRT1

Daré Bioscience, Inc. recently announced the initiation of a Phase 1/2 clinical study of DARE-HRT1. DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy (HT) regimen to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. Topline data reported in 2021 from a Phase 1 study evaluating pharmacokinetics (PK) of two different dose versions of DARE-HRT1 over 28 days support DARE-HRT1’s potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of menopause.

The open-label Phase 1/2 study that has been initiated will evaluate the PK of the same two dose versions of DARE-HRT1 (estradiol 80 µg/progesterone 4 mg IVR and estradiol 160 µg/progesterone 8 mg IVR) in approximately 20 healthy, post-menopausal women over approximately three consecutive months of use. The study will also collect safety, usability, acceptability and symptom-relief data. The study is being conducted by the company’s wholly owned subsidiary in Australia.

“For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, such as hot flashes and vaginal dryness, and may also prevent bone loss and fracture,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE-HRT1’s potential to be a first-in-category option offering ease-of-use and consistent dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks.”

The North American Menopause Society’s guidance on hormone therapy includes that dosing estrogen and progestogen in combination may offer important benefits to women and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies.

The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other vaginal ring technologies, Daré’s IVR drug delivery technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery. Baseline-corrected steady state release level data from the prior Phase 1 study demonstrate that both dose versions of DARE-HRT1 successfully delivered two different bio-identical hormones over the 28-day evaluation period.

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 the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the US.

Menopause is defined as the final menstrual period and is typically confirmed after a woman has missed her period for 12 consecutive months. Most women experience menopause between ages 40 and 58. An estimated 45 million women in the US are approaching or in menopause, which results in a decrease in estrogen and other hormones. Hot flashes, vaginal dryness, and loss of bone density are frequently associated with menopause. Night sweats (hot flashes that occur during sleep) often cause sleep disturbance, and vaginal atrophy (the drying and thinning of vaginal tissues) can cause a feeling of vaginal tightness during sex along with pain, burning, or soreness. Hence, management of menopausal symptoms can impact quality of life, productivity and health. The North American Menopause Society (NAMS) believes that hormone therapy is the most effective treatment for VMS and the genitourinary syndrome of menopause and observes that a non-oral route may offer advantages over oral routes of administration.

Daré Bioscience is a biopharmaceutical company committed to advancing 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 prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health. Daré’s first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel, 2%), is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. The Company’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly contraceptive whose U.S. 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; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.