DARE-HRT1 is a potential treatment of menopause-related symptoms
DARE-FRT1 is a potential pregnancy maintenance therapy
SAN DIEGO, July 22, 2019 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that it will be presenting two posters at the 2019 Controlled Release Society Annual Meeting & Exposition taking place in Valencia Spain, July 21st-24th.
The presentations will focus on recently completed studies designed to determine drug concentration and release characteristics for DARE-HRT1 and DARE-FRT1, novel intravaginal ring (IVR) drug delivery product candidates containing bio-identical hormones being developed for the treatment of menopause-related vasomotor symptoms (VMS) and luteal phase pregnancy maintenance, respectively.
“The findings from these studies demonstrate that FT-Raman spectroscopy and hot-melt extrusion are useful analytical tools to assess the physical state of active drug products as part of quality control and long-term stability assessments, to evaluate and demonstrate stability of the active drug in the IVR over time,” said Dr. David Friend, Chief Scientific Officer of Daré Bioscience.
DARE-HRT1 is a novel, segmented ethylene-vinyl acetate (EVA) IVR delivering bioidentical 17β-estradiol and bioidentical progesterone, and DARE-FRT1 is a novel, segmented IVR delivering progesterone. These two product candidates are the most advanced products from Daré’s IVR technology platform that was initially developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other IVR product designs, Daré’s IVR technology is designed to allow for active drug to be homogenized in a solid EVA polymer matrix that eliminates the need for a membrane or reservoir to contain the active drug or control its release. Individual drug segments provide the opportunity for multiple drug and dosage level options. Compared to other drug delivery vehicles, these features provide flexibility to incorporate a wide molecular weight range, including poorly bioavailable drugs.
The poster presentations will be led by Dr. Friend. on Monday, July 22, 2019, and Tuesday, July 23, 2019, 5:30 PM – 7:30 PM (CET). The posters are titled:
- Determination of Drug Crystallinity in Hot Melt Extruded Ethylene Vinyl Acetate Copolymer
- Use of FT‐Raman Spectroscopy to Assess 17β‐Estradiol/Progesterone Ethylene Vinyl Acetate Based Intravaginal Rings
The posters will also be made available on the Events and Presentations page of Daré’s investor relations website (http://ir.darebioscience.com).
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of 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 expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.
Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; 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 replacement therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré uses these channels to communicate with its investors and the public about the company and other company-related matters. The information Daré posts on its investor relations website may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website: www.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,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential of DARE-HRT1 to treat menopause-related vasomotor symptoms and of DARE-FRT1 to provide effective pregnancy maintenance therapy. 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, risk and uncertainties related to: Daré’s ability to raise additional capital when and as needed, to advance its product candidates; Daré’s 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 Daré’s product candidates in a timely manner; Daré’s ability to conduct and design 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 ability to retain its licensed rights to develop and commercialize a 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 candidates; developments by Daré’s competitors that make its product candidates less competitive or obsolete; Daré’s dependence on third parties to conduct clinical trials and manufacture clinical trial material; 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; the risk of failure associated with product candidates in preclinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund; 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.
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Source: Daré Bioscience