Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 30

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 30
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 evaluated four dose levels of DARE-VVA1 (1 mg, 5 mg, 10 mg, and 20 mg tamoxifen) and a placebo. Following a screening visit, DARE-VVA1 was self-administered by study participants intravaginally once a day for the first two weeks, and then twice a week for the following six weeks for a total treatment period of 56 days. In each treatment group, participants had serial blood sampling for PK analysis and underwent safety evaluations and preliminary assessments of effectiveness. Following the completion of the treatment period, participants attended a safety follow- up visit. Fourteen participants completed the study. The primary endpoints of the study evaluated the safety and tolerability of DARE-VVA1 by vaginal administration and determined the plasma PK of DARE-VVA1 after intravaginal application. Secondary endpoints evaluated preliminary efficacy and PD of DARE-VVA1 in terms of the most bothersome vaginal symptom and changes in vaginal cytology and pH. In November 2022, we announced topline results from the Phase 1/2 study of DARE-VVA1. In 2023, data from the study were published in Climacteric, the official journal of the International Menopause Society, in an article entitled, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy.” The article concluded that DARE-VVA1 resulted in minimal systemic exposure to tamoxifen. Adverse events were mild to moderate in severity and distributed similarly among the DARE-VVA1 and placebo groups. Of the 15 participants who reported at least one TEAE, nine reported a TEAE related to the reproductive system, with vulvovaginal discomfort (n=5 participant reports) and vulvovaginal pruritus (n=4 participants reports) being the most common organ system preferred term. The mean local erythema scores for all visits, for all dosing groups, were in the none\absent (0) to mild (1) range, with a few outliers in the moderate (2) grading, with no discernible pattern or correlation to group. All endometrial width measurements assessed with transvaginal ultrasound were normal at baseline and at 57 days of treatment, with the maximum measurement not exceeding 4.0 mm. Plasma tamoxifen concentrations were highest among women using DARE- VVA