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Dare (DARE) Begins Study to Treat Vulvar and Vaginal Atrophy

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Daré Bioscience (DARE - Free Report) announced that it has initiated a phase I/II study to evaluate its investigational proprietary formulation, DARE-VVA1, for non-hormonal treatment of moderate to severe vulvar and vaginal atrophy (“VVA”), an inflammation of the vaginal epithelium resulting from a reduction in estrogen levels.

DARE-VVA1 is a novel formulation of tamoxifen designed for intravaginal administration to exert an estrogen-like response on vaginal cytology for the treatment of VVA. Unlike other VVA treatments that are predominantly based on estrogen, DARE-VVA1 offers treatment to VVA without the use of estrogen.

VVA is a common condition in postmenopausal women and women with hormone receptor-positive (“HR+”) breast cancer. It is marked by vaginal dryness, itching, burning and painful intercourse.

The stock has rallied 31.3% so far this year in comparison with the industry’s 0.7% rise.

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The phase I/II study will evaluate the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of DARE-VVA1 in 40 postmenopausal participants with moderate to severe VVA. The study will randomize the patients into five equal treatment groups, i.e., four different doses of the therapy, namely 1 mg, 5 mg, 10 mg, and 20 mg, and placebo.

The primary endpoints include assessing the safety and tolerability of vaginal administration of the therapy including assessment of the therapy’s plasma PK after intravaginal application. Secondary endpoints include evaluation of the therapy’s preliminary efficacy and PD in terms of most bothersome symptoms, and changes in vaginal cytology and pH.

Per the company, approximately 10% of women living in the United States develop breast cancer. Moreover, VVA is commonly found in 42-70% of postmenopausal breast cancer patients. If approved, DARE-VVA1 will be the first therapy for the treatment of VVA for women with HR+ breast cancer.

Zacks Rank & Stocks to Consider

Daré Bioscience currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Regeneron Pharmaceuticals (REGN - Free Report) , Repligen Corporation (RGEN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Regeneron and Repligen each carry a Zacks Rank #1 (Strong Buy) at present, Vertex holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $59.80 in the past 60 days. The same for 2022 has risen from $40.91 to $46.72 over the same period. The stock has rallied 33.8% in the year so far.

Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 60 days. The same for 2022 has risen from $2.57 to $3.03 over the same period. The stock has rallied 69.2% in the year so far.

Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 60 days. The same for 2022 has risen from $12.24 to $13.13 over the same period.