Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the article entitled “Pharmacokinetics
and tolerability of a novel 17β-estradiol and progesterone
intravaginal ring in sheep” was published online in the Journal of
Pharmaceutical Sciences (JPharmSci®). The goal of the research
described in the article was to characterize the release,
pharmacokinetics and local tolerability of DARE-HRT1, a potential
and novel hormone replacement therapy. DARE-HRT1, an
ethylene-vinyl acetate (EVA) intravaginal ring (IVR) drug delivery
technology delivering 17β-estradiol (E2) and progesterone (P), was
evaluated in drug-naïve ovariectomized female Dorset crossbred
sheep.
DARE-HRT1 is being developed as a combination bio-identical
estradiol and bio-identical progesterone IVR for hormone
replacement therapy (HRT) to treat vasomotor symptoms (VMS),
commonly called hot-flashes and associated with menopause, as part
of an HRT regimen. The North American Menopause Society (NAMS)
consensus statement supports HRT in peri- and post-menopausal women
and recommends administering both estrogen to reduce symptoms and
progesterone to prevent thickening of the uterine wall, in addition
to recommending a non-oral route over an oral route.1 The design of
DARE-HRT1 is intended to allow the continuous delivery of
bio-identical estradiol and bio-identical progesterone in one IVR
over a 28- day period.
“We believe achieving predictable and sustained release rates of
bio-identical hormones in a large animal model, as published in
JPharmSci, is a validation of the viability of our IVR technology
platform,” said Dr. David Friend, co-author of the article and
Chief Scientific Officer for Daré Bioscience. “We believe the
results of this study are highly encouraging. The IVRs were well
tolerated and we saw no abnormal findings in any of the
groups.”
In a separate study of 44 healthy female post-menopausal women,
more than 90 percent said an IVR would make taking their
medications easier and 88 percent reported they would be very
likely to use an IVR for a condition related to Women’s
Health.2
“With more than 45 million women approaching menopause in the
United States, the demand for new innovation to treat HRT is
accelerating at a rapid pace,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “We are highly
encouraged by these findings and plan to advance our DARE-HRT1
program into a human clinical study this year. In addition,
we expect to advance our novel IVR-based fertility program,
DARE-FRT1, into a human clinical study in approximately 12 to 18
months.”
For full access to the JPharmSci article, please visit
https://jpharmsci.org/. For more information on Daré, please visit
www.darebioscience.com.
- Menopause, Vol. 19, No. 3, 2012.
- Leonard-Segal, Acceptability and Tolerability of an
Intravaginal Ring in Postmenopausal Women, Accepted for North
American Menopause Society, Philadelphia, PA, 11 October 2017.
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-class
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.
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 plans to
advance DARE-HRT1 into a human clinical study this year and to
advance DARE-FRT1 into a human clinical study in approximately 12
to 18 months. 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.: Alex Gray
Burns McClellan agray@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Amanda Guisbond
Canale Communications amanda@canalecomm.com 781-405-8775
Source: Daré Bioscience
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