{"id":773709,"date":"2023-07-31T09:02:33","date_gmt":"2023-07-31T13:02:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/"},"modified":"2023-07-31T09:02:33","modified_gmt":"2023-07-31T13:02:33","slug":"dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth"},"content":{"rendered":"
\n

\n 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<\/em>
\n \n <\/p>\n

\n Currently no FDA-Approved Product for the Treatment of Preterm Birth<\/em>\n <\/p>\n

SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth. Dar\u00e9 will collaborate with its sub awardee, the Lockwood Laboratory at the University of South Florida (USF) Morsani College of Medicine, on the grant-funded activities.<\/p>\n

Preterm birth is defined as a live birth before 37 completed weeks of gestation.1<\/sup>,2<\/sup> 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,<\/sup>3<\/sup><\/p>\n

\u201cWe continue to drive innovation in women\u2019s health and, in light of the FDA\u2019s 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,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9 Bioscience. \u201cWe commend the NICHD for its commitment to advancing new innovation in this critical area of unmet need and look forward to collaborating with USF on this important new development program.\u201d<\/p>\n

Under an exclusive option agreement with the University of South Florida Research Foundation, Inc. (USFRF), a nonprofit Florida corporation that is a direct support organization of USF, Dar\u00e9 has an exclusive right, and not an obligation, to elect to negotiate to acquire the exclusive worldwide rights to patents and know-how controlled by USFRF related to this research in the field of human reproduction during an option period which extends through this NIH-funded development project.<\/p>\n

According to the World Health Organization (WHO), an estimated 13.4 million babies were born preterm in 2020.4<\/sup> Preterm birth complications were responsible for the deaths of approximately 900,000 children in 2019 and complications from preterm birth are the leading cause of death among children under 5 years of age.4<\/sup><\/p>\n

    \n
  1. March of Dimes PeriStats\u2122, Preterm Birth, accessed 28 July 2023. https:\/\/www.marchofdimes.org\/peristats\/data?reg=99&slev=4&top=3<\/a><\/li>\n
  2. Mayo Clinic, Diseases & Conditions, Premature birth, accessed 28 July 2023. https:\/\/www.mayoclinic.org\/diseases-conditions\/premature-birth\/symptoms-causes\/syc-20376730<\/a><\/li>\n
  3. 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<\/a><\/li>\n
  4. WHO, Newsroom, Fact sheets, Detail, Preterm birth, accessed 28 July 2023. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/preterm-birth<\/a><\/li>\n<\/ol>\n

    \n About NICHD<\/strong>\n <\/p>\n

    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<\/a>.<\/p>\n

    \n About USF and USFRF<\/strong>\n <\/p>\n

    USF supports economic development in the Tampa Bay region and the State of Florida by educating and training students for productive careers, by supporting research and technology transfer, and by providing information and scholarly resources needed by the community.<\/p>\n

    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 USF Research Park, a community of science and technology researchers and entrepreneurs. USFRF also supports USF CONNECT and the Tampa Bay Technology Incubator (TBTI) on behalf of the university. For more information, visit https:\/\/www.usf.edu\/research-innovation\/rf\/about-usfrf.aspx<\/a>.<\/p>\n

    \n About Dar\u00e9 Bioscience<\/strong>\n <\/p>\n

    Dar\u00e9 Bioscience is a biopharmaceutical company committed to advancing innovative products for women\u2019s health. The company\u2019s 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.<\/p>\n

    Dar\u00e9\u2019s first FDA-approved product, XACIATO\u2122 (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. Dar\u00e9\u2019s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene\u00ae, 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\u00ae; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Dar\u00e9\u2019s full portfolio of women\u2019s health product candidates, and Dar\u00e9\u2019s mission to deliver differentiated therapies for women, please visit www.darebioscience.com<\/a>.<\/p>\n

    Dar\u00e9 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<\/a>), SEC filings, press releases, public conference calls and webcasts. Dar\u00e9 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 Dar\u00e9 posts on its investor relations website or through social media channels may be deemed to be material information. Dar\u00e9 encourages investors, the media, and others interested in the company to review the information Dar\u00e9 posts in the Investors section of its website and to follow these 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 Dar\u00e9\u2019s website.<\/p>\n

    \n Forward-Looking Statements<\/strong>\n <\/p>\n

    Dar\u00e9 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 \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cdesign,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201ccould,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccontemplate,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cobjective,\u201d 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, Dar\u00e9\u2019s receipt of funds under the NICHD grant award, and Dar\u00e9\u2019s 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 Dar\u00e9\u2019s 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: Dar\u00e9\u2019s 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 Dar\u00e9 anticipates; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s 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 Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives, including their potential impact on Dar\u00e9\u2019s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar\u00e9 relies to assist in the conduct of its business to fulfill their contractual obligations to Dar\u00e9; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the risk that developments by competitors make Dar\u00e9\u2019s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and\/or commercial collaborators; failure of Dar\u00e9\u2019s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a product or product candidate; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s ability to adequately protect or enforce its, or its licensor\u2019s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dar\u00e9\u2019s 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 Dar\u00e9\u2019s product or product candidates or the business activities of Dar\u00e9, its commercial collaborators or other third parties on which Dar\u00e9 relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cyber attacks, security breaches or similar events that compromise Dar\u00e9\u2019s technology systems or those of third parties on which it relies and\/or significantly disrupt Dar\u00e9\u2019s business; and disputes or other developments concerning Dar\u00e9\u2019s intellectual property rights. Dar\u00e9\u2019s 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 Dar\u00e9\u2019s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Dar\u00e9\u2019s 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. Dar\u00e9 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.<\/p>\n

    \n Contacts:<\/strong>\n <\/p>\n

    \n Investors on behalf of Dar\u00e9 Bioscience, Inc.:<\/strong>
    \n
    Lee Roth \/ Julia Weilman
    Burns McClellan
    lroth@burnsmc.com<\/a> \/ jweilman@burnsmc.com<\/a>
    646.930.4406 \/ 646.732.4443<\/p>\n

    \n Media on behalf of Dar\u00e9 Bioscience, Inc.:<\/strong>
    \n
    Jake Robison
    Evoke Canale
    jake.robison@evokegroup.com<\/a>
    619.849.5383<\/p>\n

    Source: Dar\u00e9 Bioscience, Inc.<\/p>\n

    \n
    \n
    \n \n <\/div>\n

    <\/div>\n","protected":false},"excerpt":{"rendered":"

    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 SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth. Dar\u00e9 will … <\/p>\n

    Continue reading “Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-773709","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"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 SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/","og_locale":"en_US","og_type":"article","og_title":"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth - Market Newsdesk","og_description":"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 SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth. Dar\u00e9 will … Continue reading \"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/","og_site_name":"Market Newsdesk","article_published_time":"2023-07-31T13:02:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg4MzQyNSM1NzI2NjU4IzIwMDgzNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth","datePublished":"2023-07-31T13:02:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/"},"wordCount":1913,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg4MzQyNSM1NzI2NjU4IzIwMDgzNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-grant-award-supporting-development-of-potential-new-therapeutic-intervention-for-the-prevention-of-idiopathic-preterm-birth\/","name":"Dar\u00e9 Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth - 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