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 that, based on the results of an
interim analysis to evaluate the relative magnitude of the
treatment effect, they expect to complete enrollment in the
exploratory Phase 2b RESPOND clinical study of Sildenafil Cream,
3.6% in 4Q-2022, allowing for a topline data announcement target of
2Q-2023. The interim analysis was conducted by an independent
third-party statistical resource and both Daré and SST continue to
remain blinded to results of the study by treatment group. The
Phase 2b RESPOND clinical study is a multi-center, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
Sildenafil Cream, 3.6% in premenopausal patients with female sexual
arousal disorder (FSAD).
Sildenafil Cream is a proprietary topical formulation of
sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being
developed as a first-in-category option for the treatment of FSAD.
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.
“We are thrilled to have reached this important milestone for
this study this year and look forward to evaluating the topline
data next year,” said Sabrina Martucci Johnson, President and CEO
of Daré Bioscience. “Although numerous pharmaceutical products have
been developed, tested and approved by the FDA to treat ED in men,
there are no FDA-approved options for women with FSAD, an analogous
condition. Completing this Phase 2b study will be a significant
milestone in the development of what has the potential to be the
first FDA-approved product to treat FSAD. Based on the relative
treatment effect seen in the interim analysis we are comfortable
with an enrollment target of 150 women completing the study, and
believe these Phase 2b data will facilitate ongoing discussion and
future alignment with the FDA regarding the pivotal registration
program.”
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 increased blood
flow directly to the genital tissue to improve the physical arousal
response symptoms commonly associated with FSAD. 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. This is similar to the way ED
medications work in men by directing blood flow to the genitals
when taken prior to sexual activity.
The Phase 2b RESPOND study evaluates Sildenafil Cream compared
to a placebo cream in pre- and peri-menopausal women over the
course of 12 weeks, in an at-home setting, following both a
non-drug and placebo cream run-in period. The Phase 2b RESPOND
study is a first of its kind Phase 2b study that includes patient
reported outcome (PRO) instruments to screen eligible women with
FSAD and a number of primary, secondary, and exploratory PRO
assessments to measure improvement in localized genital sensations
of arousal and reduction in the distress that women experience with
FSAD. There are no FDA-approved treatments for FSAD and thus there
are no efficacy endpoints that have been previously validated in
Phase 3 pivotal studies for potential treatments for FSAD. The
RESPOND study is designed to test the sensitivity of several
efficacy endpoints and their ability to determine a treatment
effect of Sildenafil Cream compared to placebo to inform the
ongoing development program. The independent third-party
statistical resource was provided with unblinded data in order to
determine the relative magnitude of the treatment effect to enable
a determination of next steps with study enrollment and enrollment
targets.
Market research suggests that 16% of women in
the U.S. ages 21 to 60, or approximately 10 million
women, are distressed from experiencing symptoms associated with
FSAD, including lack of or low sexual arousal, and are actively
seeking solutions to improve their condition. For context on the
potential market opportunity for an FDA-approved treatment for
FSAD, the prevalence of complete ED in men is estimated to be about
5% of men at age 40, increasing to about 15% at age 70.
About FSAD
FSAD is distinct from hypoactive sexual desire disorder (HSDD)
in women, which is characterized primarily by a lack of sexual
desire. FSAD is a condition characterized primarily by a persistent
or recurrent inability to attain or maintain sufficient genital
arousal (an adequate lubrication-swelling response) during sexual
activity, frequently resulting in distress or interpersonal
difficulty. As with ED in men, FSAD is associated with insufficient
blood flow to the genitalia.
About Sildenafil Cream, 3.6% and the Phase 2b RESPOND
Study
Sildenafil Cream is an investigational proprietary cream
formulation of sildenafil, a PDE-5 inhibitor, designed for topical
administration to the vulva and vagina to increase genital blood
flow and provide improvements in the female genital arousal
response, while avoiding systemic side effects observed with oral
formulations of sildenafil. Sildenafil Cream has been previously
evaluated in Phase 1 and Phase 2a clinical studies. In a Phase 1
clinical study in 20 healthy post-menopausal women, topical
sildenafil cream was safe and well tolerated at clinically relevant
doses, and study subjects reported favorable product
characteristics: easy to use and readily absorbed. In a Phase 2a
study in women with FSAD (15 pre-menopausal and 16
post-menopausal), Sildenafil Cream increased measurable blood flow
to the genital tissue compared to placebo cream. Further, data from
a thermography study in six healthy women demonstrated
significantly greater increases in genital temperature after
administration of Sildenafil Cream compared to placebo cream,
indicating a positive impact on genital blood flow during the
30-minute testing session, with statistical separation from placebo
within the first 15 minutes of dosing.
Prior to commencement of the Phase 2b RESPOND clinical study of
Sildenafil Cream, Daré completed a content validity study designed
to identify and document the genital arousal symptoms that are the
most important and relevant to women with FSAD. The findings of
that non-interventional study helped facilitate alignment with the
FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study
and future Phase 3 program, including a number of exploratory
endpoints identified in the content validity study. The primary
efficacy endpoint of the Phase 2b study is a composite endpoint
that includes patient-reported improvement in genital sensations of
arousal and reduction in distress associated with FSAD. While the
Phase 2b RESPOND study was originally expected to randomize a
minimum of 400 subjects into the double-blind dosing period from 40
to 50 sites in the U.S. to achieve 150 subjects per arm
completing the 12-week double-blind dosing period, based on the
analysis of unblinded data by the independent third-party
statistical resource to evaluate the relative magnitude of the
treatment effect, it was determined to complete enrollment in
4Q-2022 with a revised projected 150 subjects expected to complete
the 12-week double-blind dosing period (approximately 75 subjects
per arm). The reduction in the number of subjects should not be
viewed as indicative of the magnitude of the treatment effect. The
relative magnitude of the treatment effect seen in the interim
analysis should not be viewed as predictive that topline data will
show Sildenafil Cream achieved the efficacy endpoints of the Phase
2b study.
About Daré BioscienceDaré 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, fertility, and vaginal and sexual health. 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 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 hormone therapy following menopause. 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 StatementsDaré 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 the timing of the completion of enrollment
in the Phase 2b RESPOND clinical study and of the topline data
announcement, the potential of Sildenafil Cream, 3.6% to be
approved by the FDA, and the market potential of Sildenafil Cream,
3.6%, if approved by the FDA . 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: 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; 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; 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; the loss of, or
inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions 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 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; failure to timely
establish or maintain third-party partnerships or collaborations to
develop and/or commercialize Daré’s product and Daré’s product
candidates, if approved; 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, product candidates or business activities; 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:Investor RelationsLee RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonEvoke
Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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