Daré Bioscience Announces Positive Safety & Acceptability Data From Phase 1 Clinical Trial That Support the Potential of DARE-HRT1 Intravaginal Ring as a New Menopausal Hormone Therapy

Daré Bioscience, Inc. recently announced that Climacteric, the official journal of the International Menopause Society, published safety and acceptability results from a Phase 1 clinical trial of DARE-HRT1, an investigational ethylene vinyl acetate copolymer intravaginal ring (IVR) designed to release bio-identical 17β-estradiol (E2) and progesterone (P4) over 28 days. DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.

Hormone therapy is used to treat VMS and genitourinary syndrome associated with menopause. DARE-HRT1 has the 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. The North American Menopause Society’s (NAMS) guidance on hormone therapy states 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.

“We are very encouraged by these data which indicate that our candidate, DARE-HRT1, was well-tolerated and highly acceptable for the majority of women in both IVR treatment groups,” said David Friend, PhD, Chief Scientific Officer for Daré Bioscience. “Sharing these data from our Phase 1 trial, in a recognized peer-reviewed journal, allows us to highlight the scientific rigor of our development process and showcase our innovative IVR drug delivery technology platform.”

Approximately 30 healthy, postmenopausal women participated in the open-label, three-arm Phase 1 study. Women in first arm received one DARE-HTR1 ring for 28 days designed to release E2 at a rate of 80 μg/day and P4 at 4 mg/day, and women in the second arm received an alternative DARE-HRT1 ring for 28 days designed to release E2 at 160 μg/day and P4 at 8mg/day. The third arm received both oral Estrofem (1 mg E2) and Prometrium (100 mg P4) daily for 29 days. The primary objective of the study was to assess the pharmacokinetics from the two dosage strengths of the DARE-HRT1 IVRs. The secondary objective of the study was to assess the safety of the IVRs while the exploratory objectives were to assess usability and participant tolerability of the IVRs.

The study demonstrated that the DARE-HRT1 IVRs, in general, were safe and well tolerated in healthy postmenopausal women and treatment emergent adverse events profiles were comparable between the DARE-HRT1 groups and the reference oral regimen group.

“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,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This innovative drug delivery technology is designed to release one or more active ingredients without the need for a membrane or reservoir to contain the active drug(s) or to control the release, allowing for sustained drug delivery. We believe this IVR drug delivery technology platform has the potential to result in products that offer women a number of benefits as compared to currently marketed products, including the opportunity to improve medication compliance, avoid first-pass metabolic side effects, and deliver a better overall user experience.”

Previously reported topline efficacy data from a Phase 1 / 2 study of DARE-HRT1 demonstrated improvement in both VMS as well as vaginal symptoms of menopause. 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 US 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. Over 45 million women in the US are estimated to be 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 potential 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, vaginal health, reproductive health, menopause, sexual health, and fertility.

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, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive 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; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. For more information, visit www.darebioscience.com.