Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced completion of patient recruitment in
its pre-pivotal, postcoital test (PCT) trial of Ovaprene®. Ovaprene
is a self-administered, hormone-free, novel intravaginal ring,
similar in size and shape to NuvaRing®. Ovaprene is designed
to achieve contraceptive effectiveness over multiple weeks without
the use of hormones and has the potential to be a first-in-category
contraceptive, if approved. There currently is no FDA-approved,
self-administered contraceptive that can provide month-to-month
contraceptive protection without the use of hormones.
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 Journal of Reproductive Medicine, which demonstrated
Ovaprene was successful at blocking sperm from entering the
cervical canal, coupled with the high investigator and patient
interest in this more robust pre-pivotal PCT trial that we have
been conducting, suggest a significant market opportunity for a
monthly, woman-controlled, hormone-free contraceptive,” said
Sabrina Martucci Johnson, President and Chief Executive Officer of
Daré Bioscience.
According to data from the Centers for Disease Control and
Prevention (CDC), in 2015 to 2017, approximately 65% of the more
than 72 million women of reproductive age (ages 15 to 49) in the
U.S., or more than 46 million women, were currently using
contraception. Non-discounted spending on prescription
contraceptives in the U.S. has exceeded $5 billion annually.
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 FDA to commence a pivotal clinical trial
in women at risk for pregnancy.
About Ovaprene
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 Eunice Kennedy
Shriver National Institute of Child Health and Human Development of
the National Institutes of Health under Award Number R44HD095724,
is designed to assess the ability of Ovaprene to prevent sperm from
penetrating midcycle cervical mucus following intercourse and the
general safety, acceptability and fit of Ovaprene in healthy,
sexually active women who are not at risk for pregnancy due to
previous female tubal sterilization. The study has a target
of having at least 25 women complete a total of 21 visits. Women
are evaluated over the course of five menstrual cycles, including a
baseline measurement excluding the use of any product (during
menstrual cycle 1), using a diaphragm (during menstrual cycle 2)
and using Ovaprene (during menstrual cycles 3, 4 and 5).
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.
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. Such statements
include, but are not limited to, statements relating to the
potential of Ovaprene to be the first FDA-approved monthly,
self-administered, hormone-free contraceptive, the market
opportunity for Ovaprene and the timing of reporting top-line data
from the Ovaprene pre-pivotal PCT clinical trial. 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth Burns McClellan lroth@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Jake
RobisonCanale Communications
jake@canalecomm.com 619-849-5383
Source: Daré Bioscience
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