Benzinga | Sep 23, 2021 08:05AM EDT

Dare Bioscience Reports Initiation Of Phase 1/2 Study Of DARE-VVA1 For Treatment Of Vulvar, Vaginal Atrophy

Dar? 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, Dar?'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."

The Phase 1/2 study will evaluate different doses of DARE-VVA1, a tamoxifen vaginal insert, in approximately 40 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, doseranging study that will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DAREVVA1. Eligible participants will be randomly allocated to one of five treatment groups (approximately 8 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, DAREVVA1 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. Secondary endpoints will evaluate preliminary efficacy and PD of DARE-VVA1 in terms of most bothersome symptom and changes in vaginal cytology and pH.

"Women navigating breast cancer treatment face many challenges and hardships in addition to those we commonly think about, including VVA," said James A. Simon, MD, CCD, NCMP, IF, FACOG, Clinical Professor of Obstetrics and Gynecology at The Washington University School of Medicine, and Medical Director and Founder of IntimMedicine Specialists(r). "Having a safe and effective, non-hormonal therapy to address the uncomfortable symptoms of VVA could offer both physical and psychological benefits to patients and survivors. I look forward to following the progression of DARE-VVA1 as a potential first-in-category hormone-free vaginal treatment for VVA."