{"id":809811,"date":"2025-02-06T08:06:47","date_gmt":"2025-02-06T13:06:47","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-funding-award-notice-from-the-national-institutes-of-health-nih-national-institute-of-allergy-and-infectious-diseases-niaid-to-support-dare-hpv-development\/"},"modified":"2025-02-06T08:06:47","modified_gmt":"2025-02-06T13:06:47","slug":"dare-bioscience-announces-funding-award-notice-from-the-national-institutes-of-health-nih-national-institute-of-allergy-and-infectious-diseases-niaid-to-support-dare-hpv-development","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-funding-award-notice-from-the-national-institutes-of-health-nih-national-institute-of-allergy-and-infectious-diseases-niaid-to-support-dare-hpv-development\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to Support DARE-HPV Development"},"content":{"rendered":"
\n

\n DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management<\/strong>\n <\/p>\n

\n Essentially all cervical cancer cases worldwide are caused by HPV infection<\/strong>\n <\/p>\n

\n Up to $2 million in grant funding may be provided by NIAID to support DARE-HPV development, bringing total non-dilutive funding for DARE-HPV advancement to up to $12 million<\/strong>\n <\/p>\n

SAN DIEGO, Feb. 06, 2025 (GLOBE NEWSWIRE) — Dare\u0301\u00a0Bioscience, Inc.\u00a0(NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it received a Notice of Award of a grant from the\u00a0National Institute of Allergy and Infectious Diseases\u00a0(NIAID), a component of the\u00a0National Institutes of Health\u00a0(NIH). The award will support non-clinical activities to support the development of DARE-HPV.<\/p>\n

DARE-HPV is an innovative investigational treatment for HPV-related cervical disease. Essentially all cervical cancers worldwide are caused by HPV infection, and despite the advancements in HPV screening and vaccination, an estimated 100,000 women are still treated for cervical precancer and an estimated 4,000 women still die from cervical cancer in the\u00a0U.S.\u00a0every year. Today, cervical precancers are monitored until they reach a late stage, since the most common treatment is a surgery which removes part of the cervix; however, the surgery is associated with an increased risk of preterm birth and sexual dysfunction and therefore is not recommended for patients with fertility concerns.<\/p>\n

\u201cDARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well as earlier stage HPV-related cervical infections, which could change the paradigm around how HPV-related cervical diseases are clinically managed today,\u201d said\u00a0Sabrina Martucci Johnson, President and CEO of Dare\u0301 Bioscience. \u201cWe are striving to transform the management of HPV-related cervical diseases with this at-home strategy to control the virus that causes cervical cancer.\u201d<\/p>\n

In October 2024, Dar\u00e9 announced<\/a> that it was selected to receive\u00a0up to $10 million\u00a0in milestone-based funding over approximately two years to support IND and Phase 2 clinical study activities for DARE-HPV.<\/p>\n

The NIAID funding award is supplemental to the previously announced $10 million award and will support non-clinical development activities that are not being conducted under that award. Dar\u00e9 is eligible to receive up to a total of approximately\u00a0$2 million\u00a0in grant funding for its DARE-HPV program based on the grant application it submitted. A grant in the amount of $1 million\u00a0has been awarded for the 2025 project year, and another $1 million\u00a0has been recommended for a subsequent project year, subject to the availability of funds and satisfactory progress of the project, as determined by NIAID.<\/p>\n

The content of this press release is solely the responsibility of Dar\u00e9\u00a0Bioscience, Inc.\u00a0and does not necessarily represent the official views of the\u00a0National Institutes of Health. This press release discusses a project that will be supported by the\u00a0National Institute of Allergy and Infectious Diseases\u00a0under Award Number 1R44AI188623-01.<\/p>\n

\n About HPV-Related Cervical Diseases and DARE-HPV<\/strong>
\n
Human papillomavirus (HPV) is the most common sexually transmitted infection in\u00a0the United States. Essentially all cervical cancers worldwide are caused by infection with one of 14 carcinogenic, or \u201chigh-risk\u201d HPV types (hrHPV). While some HPV infections are transient, persistent hrHPV infection can progress to cervical cancer through the persistence and progression of cervical lesions.<\/p>\n

DARE-HPV is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential to be a first-in-category treatment for HPV-related cervical diseases. There currently are no\u00a0U.S. Food and Drug Administration\u00a0(FDA)-approved, non-surgical pharmaceutical interventions to treat high-grade cervical lesions (also called high-grade squamous intraepithelial lesions (HSIL) or high-grade cervical intraepithelial neoplasia (CIN 2\/3)) and no FDA-approved treatments for HPV infection. DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention for the treatment of CIN and other HPV-related cervical pathologies. Activities are underway to support an investigational new drug (IND) application to the FDA to enable progression of DARE-HPV to Phase 2 clinical development in the U.S.<\/p>\n

In the\u00a0U.S., about 10% of women with HPV infection on their cervix will develop long-lasting HPV infections that put them at risk for cervical cancer. The\u00a0American Cancer Society\u00a0estimates that approximately 13,820 new cases of invasive cervical cancer will be diagnosed and more than 4,000 women will die from the disease in the\u00a0U.S.\u00a0in 2024. Additionally, each year in the\u00a0U.S., an estimated 100,000 people are treated for cervical precancer, of which approximately 74% are between the ages of 18\u201339 years, during prime childbearing and childrearing years.<\/p>\n

\n About Dar\u00e9 Bioscience<\/strong>
\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, sexual health, pelvic pain, fertility, infectious diseases, and menopause.\u00a0The first FDA-approved product to emerge from Dar\u00e9\u2019s portfolio of women\u2019s health product candidates is XACIATO\u2122 (clindamycin phosphate) vaginal gel 2%, 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. Visit www.xaciato.com<\/a> for information about XACIATO. Dar\u00e9\u2019s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene\u00ae, a novel, hormone-free monthly intravaginal contraceptive whose\u00a0U.S.\u00a0commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra\u00ae, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Dar\u00e9\u2019s full portfolio of women\u2019s health product candidates and mission to deliver differentiated therapies for women, please visit\u00a0www.darebioscience.com<\/a>.<\/p>\n

Dar\u00e9 Bioscience leadership has been named on the Medicine Maker\u2019s Power List and Endpoints News\u2019 Women in Biopharma 2022. In 2023, Dar\u00e9’s CEO was honored as one of Fierce Pharma\u2019s Most Influential People in Biopharma for Dar\u00e9\u2019s contributions to innovation and advocacy in the women\u2019s health space. Dar\u00e9 Bioscience placed #1 in the\u00a0Small Company\u00a0category of the San Diego Business Journal\u2019s 2023 Best Places to Work Awards.<\/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>),\u00a0SEC\u00a0filings, 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 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 Dar\u00e9\u2019s website.<\/p>\n

\n Forward-Looking Statements<\/strong>
\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 Dar\u00e9\u2019s expectation that it will receive\u00a0$10 million\u00a0in federal funding under the award announced in October 2024, the potential for up to $2 million in grant funding from NIAID, Dar\u00e9\u2019s development plans for DARE-HPV, including potential timing of a Phase 2 clinical study, DARE-HPV\u2019s potential as a safe and effective treatment for HPV-related cervical diseases, the potential for DARE-HPV to be the first FDA-approved pharmaceutical intervention for treatment of both late-stage cervical lesions as well as earlier stage HPV-related cervical infections, and the potential market opportunity for DARE-HPV, if approved. As used in this press release, the description of a product candidate as \u201cfirst-in-category\u201d is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Dar\u00e9 is developing it. 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: changes in U.S. federal government policies and budget decisions under the new presidential administration and Congress; executive actions or directives to federal agencies that temporarily freeze or permanently halt funding awards or programs; the effects of the freeze on external communications applicable to all federal health agencies within the U.S. Department of Health and Human Services, including the NIH and FDA, implemented on January 21, 2025; the potential effects of a federal funding freeze directed by a memo issued by the U.S. Office of Management and Budget on January 27, 2025; Dar\u00e9\u2019s ability to conduct the product development activities and achieve the product development and other milestones required for it to receive payments under its U.S. federal government-funded awards; the risk that anticipated federal government funding for DARE-HPV development will not be paid pursuant to an issued notice of award or subaward agreement as a result of federal government policy changes or budget decisions; 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 inherent uncertainty to outcomes of clinical trials of drug products; 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 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; 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 Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives; 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\u00a0the United States\u00a0and internationally; global trends toward health care cost containment; cybersecurity incidents 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\u00a0SEC\u00a0including Dar\u00e9\u2019s recent filings on Form 8-K, Form 10-K and Form 10-Q. You\u00a0are 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 Dar\u00e9 Bioscience Investor Relations<\/strong>
\n
\n innovations@darebioscience.com<\/a>\n <\/p>\n

Source: Dar\u00e9\u00a0Bioscience, Inc.<\/p>\n

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

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

DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management Essentially all cervical cancer cases worldwide are caused by HPV infection Up to $2 million in grant funding may be provided by NIAID to support DARE-HPV development, bringing total non-dilutive funding for DARE-HPV advancement to up to $12 million SAN DIEGO, Feb. 06, 2025 (GLOBE NEWSWIRE) — Dare\u0301\u00a0Bioscience, Inc.\u00a0(NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it received a Notice of Award of a grant from the\u00a0National Institute of Allergy and Infectious Diseases\u00a0(NIAID), a component of the\u00a0National Institutes of Health\u00a0(NIH). The award will support non-clinical activities to support the development … <\/p>\n

Continue reading “Dar\u00e9 Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to Support DARE-HPV Development”<\/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-809811","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to Support DARE-HPV Development - 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-funding-award-notice-from-the-national-institutes-of-health-nih-national-institute-of-allergy-and-infectious-diseases-niaid-to-support-dare-hpv-development\/\" \/>\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 Funding Award Notice from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to Support DARE-HPV Development - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management Essentially all cervical cancer cases worldwide are caused by HPV infection Up to $2 million in grant funding may be provided by NIAID to support DARE-HPV development, bringing total non-dilutive funding for DARE-HPV advancement to up to $12 million SAN DIEGO, Feb. 06, 2025 (GLOBE NEWSWIRE) — Dare\u0301\u00a0Bioscience, Inc.\u00a0(NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it received a Notice of Award of a grant from the\u00a0National Institute of Allergy and Infectious Diseases\u00a0(NIAID), a component of the\u00a0National Institutes of Health\u00a0(NIH). 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