Daré Bioscience, Inc.
(NASDAQ: DARE), a leader in women’s health innovation, today
announced positive findings from an investigational study designed
to evaluate the feasibility of using thermography technology to
assess the pharmacodynamics of Sildenafil Cream, 3.6% (Sildenafil
Cream) in normal healthy women.
Sildenafil is the active ingredient in a tablet for oral
administration marketed under the brand name Viagra®, which is
indicated for the treatment of erectile dysfunction (ED) in men.
Daré Bioscience, in collaboration with Strategic Science &
Technologies, LLC (SST), is developing Sildenafil Cream as a
potential treatment for female sexual arousal disorder (FSAD), a
condition analogous to ED in men. Sildenafil Cream is a
topically administered formulation of sildenafil designed to
increase local blood flow and provide a potential improvement in
genital arousal response and overall sexual experience for women.
This is similar to the way ED medications work in men by directing
blood to the genitals when taken before sexual activity.
There are no FDA-approved drugs for the treatment of FSAD. If
the clinical development program is successful, Sildenafil Cream
has the potential to be the first FDA-approved FSAD treatment
option.
“The results from the first six subjects to complete all
assessments indicate the utility of thermography technology
to detect statistically meaningful differences in genital
temperature changes, a surrogate for genital blood flow, and
support the ongoing evaluation of Sildenafil Cream as a treatment
for FSAD,” said Dr. Tuuli Kukkonen, C.Psych., an Associate
Professor in the Department of Family Relations and Applied
Nutrition at the University of Guelph in Ontario, Canada and an
established expert in thermography research. “Specifically, in this
initial small sample of healthy women, the data demonstrate
significantly greater increases in genital temperature after
administration of Sildenafil Cream compared to both placebo cream
as well as no cream at all, indicating a positive impact on genital
blood flow during the 30 minute testing session,” continued Dr.
Kukkonen.
The principal investigator for the thermography study, Dr. Irwin
Goldstein, Director of Sexual Medicine at Alvarado Hospital and
Director of San Diego Sexual Medicine, is a recognized leader in
the treatment of both male and female sexual disorders and the 2009
recipient of the World Association for Sexual Health Gold Medal
award in recognition of lifetime contributions to the field. “We
are encouraged by these findings as we believe these results
further validate Sildenafil Cream as a potential treatment for FSAD
as an on-demand solution to prepare the body for a more pleasurable
sexual experience,” said Dr. Goldstein.
“This study is part of our larger FSAD development program for
Sildenafil Cream, and these findings give us greater insight into
the physiologic activity and time-to-effect that we should expect
to see in the larger studies currently planned for the program,”
said Sabrina Martucci Johnson, President & CEO of Daré
Bioscience.
During the thermography study, genital temperature, a surrogate
for genital blood flow, was captured and recorded utilizing an
infrared camera capable of detecting heat patterns from blood flow
in body tissues. The study, which was designed to evaluate up to 10
subjects, achieved the study objectives based on a planned interim
analysis of the first 6 completed subjects, and thus additional
subjects will not be enrolled. The assessments consisted of
the screening visit (visit 1), the double-blind dosing of placebo
or active Sildenafil Cream (visits 2-3) and a safety follow-up. The
thermography study is part of a comprehensive clinical development
and regulatory plan for Sildenafil Cream that Daré Bioscience
intends to implement in collaboration with SST. The development
plan includes an ongoing non-interventional study intended to
support the validity of FSAD-specific patient reported outcome
(PRO) measures to be utilized to assess efficacy of Sildenafil
Cream in Phase 2 and Phase 3 clinical studies, as well as an
at-home dosing study anticipated to commence before the end of
2019, which together constitute the Sildenafil Cream Phase 2b
program.
Market research suggests that 33% of women in
the U.S., ages 21 to 60 years old, experience symptoms of low or no
sexual arousal, and 16%, or approximately 10 million women, are
distressed and are seeking a solution to improve their condition.
To put the market opportunity for an FDA-approved FSAD treatment in
context, the prevalence of complete ED is estimated to be about 5%
of men at age 40, increasing to about 15% at age 70.
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 Sildenafil Cream, 3.6% to be the first FDA-approved
FSAD treatment option, the usefulness of the thermography study to
clinical development and potential regulatory approval of
Sildenafil Cream, 3.6% for FSAD, and the timing of initiation or
completion of clinical studies of Sildenafil Cream, 3.6%.
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; the potential for results of a completed
clinical study to be different from interim findings; 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.: Jordann Phillips
Canale Communicationsjordann@canalecomm.com619-849-6009
Source: Daré Bioscience
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Sep 2023 to Sep 2024