Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, and Strategic Science & Technologies, LLC (SST), a
Cambridge, MA based novel topical drug delivery company, today
announced initiation of screening and enrollment for a Phase 1
clinical study using thermography to assess the pharmacodynamic and
pharmacokinetic characterization of Sildenafil Cream, 3.6%
(Sildenafil Cream), a late-stage product candidate being developed
as a potential new treatment for female sexual arousal disorder
(FSAD). The quantitative pharmacokinetic and pharmacodynamic
temperature data captured in a clinic setting in the study are
expected to complement the patient reported outcome data collected
in the ongoing Phase 2b RESPOND study, where the women use
Sildenafil Cream in their home setting.
FSAD is the inability to reach or maintain a
sufficient physical response to sexual stimulation and, of the
various types of female sexual dysfunction disorders, FSAD is most
analogous to erectile dysfunction (ED) in men. 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. Sildenafil Cream is an investigational proprietary topical
cream formulation specifically designed to increase blood flow to
the genital tissue in women. If successful, Sildenafil Cream has
the potential to be the first FDA-approved treatment for FSAD.
“This Phase 1, single-dose, double-blind,
placebo-controlled, 3-way crossover study will utilize thermography
to assess the pharmacodynamics and pharmacokinetics Sildenafil
Cream in comparison with versions of the cream without the active
ingredient, sildenafil,” said Andrea Thurman, MD, Medical Director
for Daré Bioscience. “The findings from this study, specifically
the pharmacodynamic and pharmacokinetic data, are an important part
of our comprehensive clinical development and regulatory plan for
Sildenafil Cream and will add to our existing clinical and
nonclinical data package to support the ongoing development
program.”
During the thermography study, vulvar
temperature, a surrogate for vulvar blood flow, will be recorded by
thermography in a clinic setting. Increasing blood flow to the
genital tissue, as Sildenafil Cream is designed to do, has the
potential to improve genital arousal response and overall sexual
experience for women. Unlike the oral formulations of PDE-5
inhibitors, Sildenafil Cream is designed to be applied locally to
the vaginal tissue prior to sexual activity to facilitate
vasodilation and increase blood flow directly to the genital tissue
to improve the physical arousal response to address the lack of
those genital arousal sensations commonly associated with FSAD.
“We are excited to announce that enrollment is
underway in this important supplemental thermography study,” said
Sabrina Martucci Johnson, President & CEO of Daré Bioscience.
“This study has the potential to provide additional quantitative
data regarding the ability of our cream formulation of the active
ingredient sildenafil to increase genital blood flow, as assessed
by vulvar temperature. These data are expected to complement
forthcoming clinical findings from our Phase 2b RESPOND trial in
preparation for a Phase 3 program.”
The Phase 1 thermography study of Sildenafil
Cream is expected to enroll approximately 15 women and be completed
in 2023.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company
committed to advancing 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 prioritize
women's health and well-being, expand treatment options, and
improve outcomes, primarily in the areas of contraception, vaginal
health, reproductive health, menopause, sexual health and
fertility.
Daré’s first FDA-approved product, XACIATO™
(clindamycin phosphate) vaginal gel, 2% is a lincosamide
antibacterial indicated for the treatment of bacterial vaginosis in
female patients 12 years of age and older, which is under a global
license agreement with Organon. XACIATO is a clear, colorless,
viscous gel, to be administered once intravaginally as a single
dose. Daré’s portfolio also includes potential first-in-category
candidates in clinical development: Ovaprene®, a novel,
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®; and DARE-HRT1, a combination bio-identical
estradiol and progesterone intravaginal ring for menopausal hormone
therapy. To learn more about XACIATO, Daré’s full portfolio of
women’s health product candidates, and Daré’s mission to deliver
differentiated therapies for women, please visit
www.darebioscience.com.
Daré may announce material information about its
finances, product and 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 and 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 in
the Investors section of Daré’s website.
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,” “objective,” 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
anticipated timing of topline data from the Phase 2b RESPOND study
of Sildenafil Cream, expectations regarding the Phase 1
thermography study of Sildenafil Cream, and the potential for
Sildenafil Cream to be the first FDA-approved treatment for FSAD.
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, execute its business strategy and
continue as a going concern; Daré’s ability to develop, obtain FDA
or foreign regulatory approval for, and commercialize its product
candidates and to do so on communicated timelines; failure or delay
in starting, conducting and completing clinical trials of a product
candidate; 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; Daré’s dependence on third
parties to conduct clinical trials and manufacture and supply
clinical trial material and commercial product; the risk that
development of a product candidate requires more clinical or
nonclinical studies than Daré anticipates, or that the duration of
a study or number of study subjects must be significantly greater
than anticipated; the risk that positive findings in early clinical
and/or nonclinical studies of a product candidate may not be
predictive of success in subsequent clinical and/or nonclinical
studies of that candidate; the loss of, or inability to attract,
key personnel; the effects of the COVID-19 pandemic, macroeconomic
conditions such as inflation, rising interest rates and
geopolitical events 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 commence, 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 to fulfill their contractual
obligations to Daré; the risk that developments by competitors make
Daré’s product or product candidates less competitive or obsolete;
difficulties establishing and sustaining relationships with
development and/or commercial collaborators; failure of Daré’s
product or product candidates, if approved, to gain market
acceptance or obtain adequate coverage or reimbursement from
third-party payers; Daré’s ability to retain its licensed rights to
develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental
investigations or actions relating to Daré’s product or product
candidates or the business activities of Daré, its commercial
collaborators or other third parties on which Daré relies; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth
Burns McClellan
lroth@burnsmc.com
646.930.4406
OR
Media on behalf of Daré Bioscience, Inc.:
Jake Robison
Evoke Canale
jake.robison@evokegroup.com
619.849.5383
Source: Daré Bioscience, Inc.
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