Daré Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth
Grant Funds Will Support Proof-of-Concept Target Validation Studies for Preclinical Development of a Potential New Approach for the Prevention and Treatment of Idiopathic Preterm Birth
Currently no FDA-Approved Product for the Treatment of Preterm Birth
Preterm birth is defined as a live birth before 37 completed weeks of gestation.1,2 Premature babies often have serious health problems. These problems can vary in severity and the earlier a baby is born, the higher the risk of health-related complications, including difficulty maintaining normal body temperature, difficulty breathing or feeding, and susceptibility to severe infections and brain disorders.2,3
“We continue to drive innovation in women’s health and, in light of the FDA’s recent decision to withdrawal its approval of the only product indicated to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, we believe that developing new therapeutic options for pregnant women at risk of delivering preterm is an area of urgent unmet need,” said
Under an exclusive option agreement with the
According to the
- March of Dimes PeriStats™, Preterm Birth, accessed
28 July 2023. https://www.marchofdimes.org/peristats/data?reg=99&slev=4&top=3 Mayo Clinic, Diseases & Conditions, Premature birth, accessed 28 July 2023. https://www.mayoclinic.org/diseases-conditions/premature-birth/symptoms-causes/syc-20376730 WHO, Newsroom, Questions and answers, Newborn health: Challenges facing preterm babies, accessed 28 July 2023. https://www.who.int/news-room/questions-and-answers/item/newborn-health-challenges-facing-preterm-babies WHO, Newsroom, Fact sheets, Detail, Preterm birth, accessed 28 July 2023. https://www.who.int/news-room/fact-sheets/detail/preterm-birth
NICHD funds research in areas relevant to normal and abnormal human development, including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, childhood development through adolescence, intellectual and developmental disabilities, and rehabilitation medicine. For more information, visit http://www.nichd.nih.gov.
About USF and USFRF
USF supports economic development in the
USFRF supports this mission and enhances the research activities of USF faculty, staff, and students. Through its programs, USFRF brings together the strengths of USF and the region to provide a critical interface that stimulates high-tech and biotech industries and creates jobs. USFRF, a not-for-profit, direct-support organization (DSO), owns and operates the
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
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),
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 the development of a new therapeutic product for the prevention and treatment of idiopathic preterm birth, Daré’s receipt of funds under the NICHD grant award, and Daré’s collaboration with USF and potential acquisition of an exclusive worldwide license from USFRF relating to the new development program for prevention and treatment of preterm birth. 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; 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; 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 loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, and public health emergencies on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including their potential impact 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
Media on behalf of Daré
Source: Daré Bioscience, Inc.