Press Release
Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1 - a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy - in Climacteric, the Journal of the International Menopause Society
“We are excited to have this peer-reviewed article published in the International Menopause Society’s journal, Climacteric, and share our findings with the broader women’s health community,” said
Daré is developing DARE-VVA1 as a new hormone-free treatment option to address moderate to severe VVA. If successful, DARE-VVA1 has the potential to be an important therapeutic for the treatment of VVA for women currently or previously treated for hormone-receptor positive (HR+) breast cancer and for other women who would like a vaginal, non-hormonal option for VVA treatment.
Globally, breast cancer is the most frequently diagnosed cancer type, accounting for over two million cases each year. Approximately 4 million
“The unmet need for an effective non-hormonal treatment for VVA caused by anti-cancer endocrine therapy in patients diagnosed with HR+ breast cancer is undeniable. The current lineup of estrogen-based therapies, commonly used to treat VVA in non-cancer patients, can be challenging for both HR+ breast cancer patients and their providers as the use of estrogen products, in any form, is often contraindicated for the HR+ breast cancer patient population,” said
The journal article is available online: https://doi.org/10.1080/13697137.2023.2211763
In
Daré is conducting activities to support submission of an Investigational New Drug (IND) application and initiation of a Phase 2 clinical study of DARE-VVA1.
About Vulvovaginal Atrophy (VVA)
VVA is an inflammation and thinning of the vaginal epithelium due to the reduction in levels of circulating estrogen. Typical symptoms include vaginal dryness, itching, burning, and painful intercourse, adversely impacting quality of life. VVA is a common condition in postmenopausal women and women with, or with a history of, HR+ breast cancer. Many breast cancer survivors experience menopausal symptoms irrespective of age as a direct consequence of their cancer treatment. Breast cancer patients treated with aromatase inhibitors refer to VVA as one of the most unpleasant side effects of treatment. The prevalence of VVA in postmenopausal breast cancer patients is estimated to be between 42 and 70 percent.
Commonly used therapies for VVA are estrogen based and are often contraindicated in HR+ breast cancer patients, or patients with a genetic predisposition or history of familial disease, because of the concern that estrogen use will promote recurrence or occurrence of disease.
About DARE-VVA1
DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration. Daré is developing DARE-VVA1 as a hormone-free alternative to estrogen-based therapies for the treatment of moderate to severe VVA. Tamoxifen is a well-known and well-characterized selective estrogen receptor modulator (SERM) that has been prescribed by oncologists for decades for the treatment of breast cancer. Tamoxifen has unique properties that produce different effects (estrogen agonist or estrogen antagonist) in different types of tissues. In breast tissue, tamoxifen acts as an estrogen antagonist, meaning that it can inhibit estrogen's effect and hence why it may be effective in treating HR+ breast cancer. In contrast, in other tissues such as vaginal tissues, tamoxifen has been reported to elicit an estrogen-like response. This has the potential to have a favorable effect on vaginal cytology. Studies of tamoxifen conducted over the last 40 years have documented its estrogen-like effects on vaginal epithelium. Localized tamoxifen therapy such as DARE-VVA1 thus has the potential to counter the physiologic changes that lead to VVA without introducing estrogen back into the system.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.
Daré’s first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com),
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-VVA1’s potential as a safe and effective therapy for VVA, DARE-VVA1’s potential to be a VVA treatment option for the HR+ breast cancer population, the potential market opportunity for DARE-VVA1, the importance of the results of the Phase 1/2 clinical study to Daré and DARE-VVA1, and the anticipated regulatory approval pathway and next steps for development of DARE-VVA1. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré’s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; the impact of pharmaceutical industry regulation and health care legislation in
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Source: Daré
Source: Daré Bioscience, Inc.