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Daré Bioscience Initiates Phase 1/2 Clinical Study of DARE-VVA1, Intravaginal Tamoxifen for the Treatment of Vulvar and Vaginal Atrophy

Investigational therapy for women who cannot, or should not, take supplemental estrogen

Potential to be the first treatment for vulvar and vaginal atrophy specifically developed for patients with hormone receptor-positive breast cancer, if approved

SAN DIEGO, Sept. 23, 2021 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the initiation of a Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal tamoxifen product being developed for the treatment of moderate to severe vulvar and vaginal atrophy (VVA). The randomized, double-blind, placebo-controlled study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA and is being conducted by the company’s wholly owned subsidiary in Australia.

“Vulvar and vaginal atrophy is an inflammation of the vaginal epithelium associated with lower estrogen levels as a result of menopause and certain cancer treatments and its symptoms adversely impact quality of life for women. Today, therapies for VVA are predominantly based on estrogen; however, there is a large unmet need for a novel non-hormonal VVA treatment specifically developed for women who have VVA as a result of treatment for hormone receptor-positive breast cancer, as well as for other women, who require or prefer a treatment option for VVA that does not contain estrogen,” said Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer. “We’re encouraged by an exploratory study of intravaginally administered tamoxifen published in Clinical and Experimental Obstetrics and Gynecology , that demonstrated improvements in vaginal pH and vaginal dryness without significant systemic absorption of tamoxifen in postmenopausal women with VVA,1 together with studies of tamoxifen conducted over the last 40 years that have documented its estrogen-like effects on the vaginal epithelium. We’re excited for the clinical advancement of DARE-VVA1 as a potential non-hormonal treatment alternative for this population.”

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