DARE-PTB1 is being developed as a treatment to reduce the risk of preterm birth, for which there are no FDA-approved treatment options
Up to approximately $2 million in grant funding to support DARE-PTB1 Phase 1 human clinical study
SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of Daré’s novel, investigational intravaginal ring (IVR), DARE-PTB1. DARE-PTB1 is designed to deliver bio-identical progesterone continuously for up to a 14-day period and is being developed as a treatment for the prevention of preterm birth in at-risk women, for which there are currently no FDA-approved treatments.
“The World Health Organization estimates that globally, 13.4 million babies were born preterm in 2020, before 37 weeks of gestation and that complications from preterm birth are the leading cause of death among children under 5 years of age1,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Daré is committed to addressing persistent unmet needs in women’s health and preterm birth is a large category that could benefit from new treatment options to protect women and babies. We are grateful to the NICHD for its support and commitment to innovation in this important therapeutic area and look forward to advancing DARE-PTB1, which has the potential to be the only FDA-approved product to reduce the risk of preterm birth.”
Daré’s IVR technology is designed to allow for sustained drug delivery over time periods ranging from weeks to months as a self-administered progesterone vaginal system.
In January 2023, Daré announced positive pharmacokinetic results from its Phase 1 / 2 clinical trial of DARE-HRT1, an investigational product which uses the same IVR technology as DARE-PTB1 to deliver non-oral, bio-identical progesterone and estradiol for the treatment of menopausal symptoms.
“The positive pharmacokinetic results from our DARE-HRT1 Phase 1 / 2 study validate the potential of Daré’s IVR technology to continuously deliver hormone therapy over multiple consecutive weeks,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “We look forward to applying the learnings from that study to our DARE-PTB1 program and the work that the NICHD award will support.”
Daré is eligible to receive up to a total of approximately $2 million in grant funding for its DARE-PTB1 program based on the grant application it submitted to support a DARE-PTB1 Phase 1 human clinical study. Approximately $1 million is available through 2024 and the award of the remaining approximately $1 million is subject to the availability of funds and satisfactory progress of the project, as determined by NICHD.
The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health. This press release discusses a project that will be supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number 4R44HD101169-02.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit http://www.nichd.nih.gov.
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. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.
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), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
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-PTB1’s potential as a safe and effective treatment for prevention of preterm birth, Daré’s Phase 1 clinical development plans for DARE-PTB1, the potential total funding amount from NICHD in support of a Phase 1 clinical study of DARE-PTB1, DARE-PTB1’s potential to be the only FDA-approved product to reduce the risk of preterm birth, and the potential market opportunity for DARE-PTB1, if approved. 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, risks 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 the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; 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 macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
Media and Investors on behalf of Daré Bioscience, Inc:
Camilla White / Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré Bioscience, Inc.
1 World Health Organization, Preterm birth key facts [accessed 2023 Dec 5]. https://www.who.int/news-room/fact-sheets/detail/preterm-birth
