Dare Bioscience Investor Presentation Deck
DARE-VVA1 - Phase 1/2 Study
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Phase 1/2 study¹ 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.
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The Phase 1/2 study will evaluate different doses of DARE-VVA1, a tamoxifen vaginal insert, in approximately 15-20 postmenopausal
women with VVA, including a cohort of women with a history of breast cancer.
The study is a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that will evaluate the
safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.
Eligible participants will be randomly allocated to one of five treatment groups (up to 5 participants per group) that will evaluate
four dose levels (1 mg, 5 mg, 10 mg, and 20 mg) and a placebo.
Following a screening visit, DARE-VVA1 will be self-administered 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 will have serial blood sampling for PK analysis and undergo safety evaluations and preliminary
assessments of effectiveness. Following the completion of the treatment period, participants will attend a safety follow-up visit.
The primary endpoints of the study will evaluate the safety and tolerability of DARE-VVA1 by vaginal administration and determine
the plasma PK of DARE-VVA1 after intravaginal application.
1. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-initiates-phase-12-clinical-study-dare-wa1
Secondary endpoints will evaluate preliminary efficacy and PD of DARE-VVA1 in terms of most bothersome symptom and changes in
vaginal cytology and pH.
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