Daré Bioscience, Inc. (NASDAQ: DARE), a
leader in women’s health innovation, today announced the
presentation of positive findings from a previously reported
investigational study that used thermography technology to assess
the pharmacodynamics of Sildenafil Cream, 3.6% (Sildenafil Cream)
in healthy women. The presentation was made at the International
Society for the Study of Women’s Sexual Health (ISSWSH) Annual
Meeting 2020, which took place in Orlando, FL, March 5-8, 2020.
Female Sexual Arousal Disorder (FSAD), a condition characterized
primarily by an inability to attain or maintain sufficient genital
arousal during sexual activity, is analogous to erectile
dysfunction (ED) in men, and sildenafil is the active ingredient in
a tablet for oral administration currently marketed under the brand
name Viagra® for the treatment of ED in men.
Daré Bioscience, in collaboration with Strategic Science &
Technologies, LLC (SST), is developing Sildenafil Cream as a
potential treatment for FSAD. Sildenafil Cream is a topically
administered formulation of sildenafil, a PDE5 inhibitor, designed
to increase local blood flow and provide a potential improvement in
genital arousal utilizing the same pathway that is active in ED
medications for men.
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.
“While oral sildenafil is effective for men, it is not an
optimized way to achieve the same response in women,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “With the
potential to deliver sildenafil in a fast-acting cream that can be
locally applied, we may be able to offer the benefits of increased
blood flow and improvement in genital sexual arousal response
without the systemic issues observed with the oral
formulation.”
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. 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 data from this study are very encouraging,” said the
principal investigator for the study, Dr. Irwin Goldstein, Director
of Sexual Medicine at Alvarado Hospital and Director of
San Diego Sexual Medicine. “We saw statistically significant
increases in genital temperature, a surrogate for genital blood
flow, and self-reported arousal response when compared to
placebo.”
Dr. Irwin Goldstein 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.
In December 2019, Daré announced alignment with the FDA on the
design of an at-home Phase 2b clinical study of Sildenafil Cream
that it plans to initiate in 2020, including the patient reported
outcome (PRO) instruments to be used to screen eligible patients
with FSAD and to measure achievement of the primary efficacy
endpoints. The Phase 2b study is designed to evaluate
Sildenafil Cream compared to placebo cream over 12 weeks of dosing
following both a non-drug and placebo run-in period.
A copy of the presentation made at the ISSWSH Annual
Meeting is available on the Events and Presentations page of Daré’s
investor relations website (http://ir.darebioscience.com).
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 hormone-free,
monthly contraceptive intravaginal ring 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 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 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. Such statements
include, but are not limited to, statements relating to the
potential of Sildenafil Cream to successfully treat FSAD without
the systemic issues observed with the oral formulation of
sildenafil, the usefulness of the thermography study to clinical
development and potential regulatory approval of Sildenafil Cream
for FSAD, and the design and timing for initiation of the Phase 2b
clinical study of Sildenafil Cream in FSAD patients.
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;
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 risk that positive findings in early clinical
studies of a product candidate may not be predictive of success in
subsequent clinical studies of that candidate; the risk that a
product candidate may fail to demonstrate equivalent or superior
efficacy and/or safety in a pivotal clinical study compared to
results from a pre-pivotal study or studies; 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 Robison
Canale Communications jake@canalecomm.com 619.849.5383
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