Daré Bioscience Completes Recruitment in Pre-Pivotal Trial Of Monthly Woman-Controlled, Hormone-Free Contraceptive Candidate, Ovaprene®
Ovaprene’s proprietary design integrates a permeable polymer matrix barrier in the center of a small silicone ring with the release of a locally acting agent that impedes sperm motility. This unique dual approach of a physical barrier and spermiostatic environment is designed to provide a contraceptive effect consistent with the most effective barrier option, the diaphragm, and commonly used short-acting hormonal options (contraceptive pill, patches and vaginal ring), which provide 88-91% effectiveness in “typical use.” All other commonly used or soon to be marketed hormone-free contraceptive products are used at, or shortly before, coitus (including condoms, spermicides, multi-purpose gels) and do not achieve “typical use” contraceptive effectiveness comparable to hormonal methods or are not self-administered (long-acting copper IUDs).
“We believe the positive data from a prior PCT trial published in the
According to data from the
Topline data from the Ovaprene PCT study are expected to be reported in the fourth quarter of 2019. If this PCT study demonstrates less than five progressively motile sperm per high powered field (< 5 PMS per HPF) in the cervical canal in most women and that Ovaprene can be safely worn over multiple weeks, Daré intends to prepare and file an Investigational Device Exemption (IDE) with the
Ovaprene is a clinical stage, woman-controlled, non-hormonal contraceptive ring intended to provide protection over multiple weeks of use, require no intervention at the time of intercourse, and create an viable new option in the hormone-free contraception method mix. It represents a new approach to contraception and, if approved, will represent a new birth control category.
About the PCT Clinical Trial
The PCT study (clinicaltrials.gov identifier: NCT03598088), which is being conducted with support from the
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 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 Daré posts on its investor relations website or through social media channels 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 (https://darebioscience.gcs-web.com/) 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 the company's website mentioned above.
This press release includes information obtained from, and makes reference to, trade and statistical services and other third-party publications and sources. Daré has not independently verified such information and, although the company is not aware of inaccuracies in such third-party information, there can be no assurance as to its accuracy.
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 Ovaprene to be the first
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Source: Daré Bioscience
Source: Dare Bioscience, Inc.