Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s
health innovation, today announced that data from the Company’s
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 studies of similar size, products (diaphragms) that
demonstrated no motile sperm in the cervical mucus during PCT
assessments later demonstrated “typical use” 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.
"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,” said
Christine Mauck, MD, Medical Director for Daré Bioscience. “These
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.”
“I 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’s potential
as an alternative to traditional hormone-based options. I am
honored to present results from the PCT study at the ACOG’s annual
meeting,” commented Andrea Thurman, MD, Professor of OBGYN at
CONRAD/Eastern Virginia Medical School and a principal investigator
in the Ovaprene PCT clinical study.
The ePoster entitled Successful Postcoital
Test Results
of a New Monthly Hormone-Free Vaginal Contraceptive,
authored by Andrea Thurman, MD, Jeffrey Baker, MD, Jeffrey
Jensen, MD, MPH, Courtney Schreiber, MD, MPH, Nadene
Zack, MS, Christine Mauck, MD, MPH, will be presented
virtually by Andrea Thurman, MD and will be available to
meeting attendees on the ACOG website at https://www.acog.org,
beginning April 30, 2021.
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
novel, investigational 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
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 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 the Investors section of its 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 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 Daré’s website mentioned above.
Forward-Looking Statements
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. In this press release, forward-looking
statements include, but are not limited to, statements relating to
Ovaprene’s potential contraceptive efficacy, Ovaprene’s potential
to be the first monthly non-hormonal prescription contraceptive
product, potential market demand for Ovaprene if approved, the
timing of Daré’s 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 Daré’s planned
contraceptive effectiveness study. 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 and
continue as a going concern; the effects of the COVID-19 pandemic
on Daré’s operations, financial results and condition, and ability
to achieve current plans and objectives, including the potential
impact of the pandemic on Daré’s ability to timely enroll, conduct
and report results of its clinical trials and on the ability of
third parties on which Daré relies to assist in the conduct of its
business, including its clinical trials, to fulfill their
contractual obligations to Daré; 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
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; 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 Daré’s
product candidates less competitive or obsolete; failure of Daré’s
product candidates, if approved, to gain market acceptance or
obtain adequate coverage from third-party payers; 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; the risks that the
license agreement with Bayer may not become effective and, if it
becomes effective, that future payments to Daré under the agreement
may be significantly less than the anticipated or potential
amounts; 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; cyber
attacks, security breaches or similar events that compromise Daré’s
technology systems or those of third parties on which it relies
and/or significantly disrupt Daré’s business; 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.
Contact:
Investors on behalf of Daré Bioscience, Inc.:Tom
MastersonAllele Capital
Partnerstmasterson@allelecapital.com646.573.3216
Source: Daré Bioscience, Inc.
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