{"id":482249,"date":"2021-04-27T08:04:55","date_gmt":"2021-04-27T12:04:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/"},"modified":"2021-04-27T08:04:55","modified_gmt":"2021-04-27T12:04:55","slug":"dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists"},"content":{"rendered":"
\n

SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that data from the Company\u2019s postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 – May 2, 2021.<\/p>\n

The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. In PCT studies of similar size, products (diaphragms) that demonstrated no motile sperm in the cervical mucus during PCT assessments later demonstrated \u201ctypical use\u201d contraceptive effectiveness of 86-91% in pivotal contraceptive studies evaluating pregnancy rates over six-month periods. If approved, Ovaprene could be the first monthly non-hormonal prescription contraceptive product addressing an important unmet need in the contraceptive method mix.<\/p>\n

“Market demographic data suggest there is a growing segment of women considering alternatives to hormonal contraceptive methods and it has already been established that there is a large segment of women who choose monthly contraceptive vaginal rings for the convenience of a non-daily option,\u201d said Christine Mauck, MD, Medical Director for Dar\u00e9 Bioscience. \u201cThese PCT clinical study data are highly encouraging and give us confidence to move Ovaprene into the next stage of clinical development, a pivotal contraceptive effectiveness study, following our Investigational Device Exemption submission to the FDA planned for later this year.\u201d<\/p>\n

\u201cI believe this study was the most robust PCT clinical study ever conducted in the field of contraception and these findings are encouraging with regard to Ovaprene\u2019s potential as an alternative to traditional hormone-based options.\u00a0 I am honored to present results from the PCT study at the ACOG\u2019s annual meeting,\u201d commented Andrea Thurman, MD, Professor of OBGYN at CONRAD\/Eastern Virginia Medical School and a principal investigator in the Ovaprene PCT clinical study.<\/p>\n

The ePoster entitled Successful\u00a0Postcoital Test Results of\u00a0a\u00a0New\u00a0Monthly\u00a0Hormone-Free\u00a0Vaginal\u00a0Contraceptive<\/em>, authored by Andrea\u00a0Thurman, MD, Jeffrey Baker, MD, Jeffrey Jensen, MD, MPH, Courtney Schreiber, MD, MPH,\u00a0Nadene Zack,\u00a0MS,\u00a0Christine Mauck, MD, MPH, will be presented virtually by Andrea\u00a0Thurman, MD and will be available to meeting attendees on the ACOG website at https:\/\/www.acog.org<\/a>, beginning April 30, 2021.<\/p>\n

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

Dar\u00e9 Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of 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 expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.<\/p>\n

Dar\u00e9\u2019s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene\u00ae, a novel, investigational 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 to treat female sexual arousal disorder utilizing the active ingredient in Viagra\u00ae; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. 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 may announce material information about its finances, 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 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 on the investor relations page of Dar\u00e9\u2019s website mentioned above.<\/p>\n

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

\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 \u201ctend to,\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 Ovaprene\u2019s potential contraceptive efficacy, Ovaprene\u2019s potential to be the first monthly non-hormonal prescription contraceptive product, potential market demand for Ovaprene if approved, the timing of Dar\u00e9\u2019s submission of an IDE to the U.S. Food and Drug Administration (FDA) for a pivotal contraceptive effectiveness and safety clinical study of Ovaprene, and the potential for FDA approval to market Ovaprene based largely on Dar\u00e9\u2019s planned contraceptive effectiveness study. 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, risk and uncertainties related to: Dar\u00e9\u2019s ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dar\u00e9\u2019s ability to timely 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, including its clinical trials, to fulfill their contractual obligations to Dar\u00e9; Dar\u00e9\u2019s ability to develop, obtain regulatory approval for, and commercialize its product candidates; the failure or delay in starting, conducting and completing clinical trials or obtaining FDA or foreign regulatory approval for Dar\u00e9\u2019s product candidates in a timely manner; 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;<\/em>
\n the risk that positive findings in early clinical and\/or nonclinical studies of a product candidate, including the Ovaprene PCT clinical study, may not be predictive of success in subsequent clinical and\/or nonclinical studies of that candidate; the risk that developments by competitors make Dar\u00e9\u2019s product candidates less competitive or obsolete; failure of Dar\u00e9\u2019s product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a 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 candidates; the risks that the license agreement with Bayer may not become effective and, if it becomes effective, that future payments to Dar\u00e9 under the agreement may be significantly less than the anticipated or potential amounts; developments by Dar\u00e9\u2019s competitors that make its product candidates less competitive or obsolete; Dar\u00e9\u2019s dependence on third parties to conduct clinical trials and manufacture clinical trial material; 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; 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\u00a0SEC\u00a0including 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.<\/em>\n <\/p>\n

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

Investors on behalf of Dar\u00e9 Bioscience, Inc.:
Tom Masterson
Allele Capital Partners
tmasterson@allelecapital.com<\/a>
646.573.3216<\/p>\n

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


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

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

SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that data from the Company\u2019s postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 – May 2, 2021. The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. In PCT … <\/p>\n

Continue reading “Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists”<\/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-482249","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists - 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-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/\" \/>\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 Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that data from the Company\u2019s postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 – May 2, 2021. The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. 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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-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/","og_locale":"en_US","og_type":"article","og_title":"Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists - Market Newsdesk","og_description":"SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) — Dar\u00e9\u00a0Bioscience, Inc.\u00a0(NASDAQ:DARE), a leader in women\u2019s health innovation, today announced that data from the Company\u2019s postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 – May 2, 2021. The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. In PCT … Continue reading \"Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/","og_site_name":"Market Newsdesk","article_published_time":"2021-04-27T12:04:55+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIyNDA4MyM0MTQwMzQ3IzIwMDgzNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists","datePublished":"2021-04-27T12:04:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/"},"wordCount":1548,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIyNDA4MyM0MTQwMzQ3IzIwMDgzNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-ovaprene-a-novel-investigational-hormone-free-contraceptive-poster-presentation-at-the-2021-annual-clinical-and-scientific-meeting-of-the-american-college-of-obstetri\/","name":"Dar\u00e9 Bioscience Announces Ovaprene\u00ae, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists - 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