Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, and its collaborator Strategic Science &
Technologies, LLC (SST), a Cambridge, MA based novel
topical drug delivery company, today announced the successful
completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food
and Drug Administration (FDA), supporting advancement of Sildenafil
Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual
arousal disorder (FSAD) to a Phase 3 clinical study. The Company
also provided an update on focus areas for 2024.
Progressing Towards Sildenafil Cream Phase 3 Pivotal
Study
The Company and the FDA aligned on key elements of the Phase 3
program to support a New Drug Application (NDA) filing, including
confirming that:
- FSAD is acceptable
as an indication.
- The trials can be
conducted in a premenopausal FSAD-only population.
- 12-weeks of blinded
treatment to assess efficacy may be acceptable, provided that the
trials are adequately powered for efficacy assessment. This is a
shorter period of blinded treatment than the 24 weeks recommended
in 2016 draft FDA guidance for developing drugs for the treatment
of low sexual interest, desire and/or arousal in women.
Additionally, the FDA indicated that feedback is forthcoming on
the following:
- Primary and
secondary patient reported outcome endpoints which will be used in
Phase 3 pivotal trials and support potential product registration
and labeling.
- Additional
information on data that may be needed in an NDA submission to
appropriately qualify any ingredient (other than sildenafil) for
the vaginal route of administration.
Daré has also requested clarification on the safety database
(size and duration of exposure) required for an NDA submission.
“We are pleased to have had a positive EoP2 meeting with the FDA
as we work towards aligning on the Phase 3 program for Sildenafil
Cream, which has the potential to address the significant unmet
need associated with arousal disorder, which impacts approximately
10 million women in the U.S.,” said Dr. Andrew Goldstein, M.D.,
Medical Advisor for Daré Bioscience. “Given that there are
currently no FDA-approved products for FSAD, we appreciate the
FDA’s guidance and support and look forward to finalizing the Phase
3 protocol as we work to advance this product candidate into its
first Phase 3 clinical study.”
The EoP2 meeting was supported by positive data from the
exploratory Phase 2b RESPOND clinical study, which assessed arousal
sensation and evaluated concerns related to difficulties with
sexual arousal over a 12-week double-blinded treatment period. The
Phase 2b study results identified the subgroup of patients most
likely to benefit from therapy and achieve a meaningful
improvement, and in those subjects demonstrated that Sildenafil
Cream improved arousal sensation, desire, orgasm, as well as
stress, guilt, and embarrassment about the sexual dysfunction. The
Phase 2b data are being used to enrich the odds of a successful
Phase 3 program. There are currently no FDA-approved therapies for
the treatment of FSAD.
Building on 2023 Achievements, Looking at
2024
In addition to the significant progress with Sildenafil Cream,
Daré continues to build on numerous milestones and achievements
from 2023.
“Continued execution against our strategy throughout 2023 has
positioned us well for 2024 as we accelerate our portfolio of novel
investigational therapies, particularly those that have already
demonstrated proof of concept and their potential to expand
treatment options, improve outcomes, and enable convenience for
women with some of the most persistent unmet needs,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “We remain
focused on advancing our key pipeline programs, including our
ongoing pivotal Phase 3 clinical study for Ovaprene, and continuing
efforts toward our goal of advancing Sildenafil Cream into Phase 3
this year. Each of these programs – if approved – represents a
potential first-in-category opportunity, and one of the most
potentially disruptive therapeutic candidates for women in
decades.”
About FSAD and Sildenafil Cream, 3.6%
FSAD, as described in the DSM-IV, is a condition characterized
as 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, and, of the
various types of female sexual dysfunction disorders, FSAD is most
analogous to erectile dysfunction (ED) in men. As with ED in men,
FSAD is associated with insufficient blood flow to the
genitalia.
Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, 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 cream
formulation of sildenafil designed for topical administration to
the vulvar-vaginal tissue on demand 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.
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. In comparison, 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 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. 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, the active ingredient in Viagra®, to
treat female sexual arousal disorder (FSAD); 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 Bioscience leadership has been named on the Medicine
Maker’s Power List and Endpoints News’ Women
in Biopharma 2022. In 2023, Daré's CEO was honored as one
of Fierce Pharma’s Most Influential People
in Biopharma for Daré’s contributions to innovation and
advocacy in the women’s health space. Daré Bioscience placed #1 in
the Small Company category of the San Diego Business
Journal’s 2023 Best Places to Work Awards.
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 X (formerly 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 Sildenafil Cream’s potential as a safe
and effective therapy for FSAD, Daré’s plans for continued clinical
development of Sildenafil Cream, including the details and
anticipated timing of commencement of a Phase 3 study, the
potential for Sildenafil Cream to be the first FDA-approved
treatment of FSAD, Daré’s program development focus for 2024, and
the potential market opportunity for Sildenafil Cream, Ovaprene and
Daré’s other investigational products. 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, risks 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 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 risk that the FDA, other regulatory
authorities, members of the scientific or medical communities or
investors may not accept or agree with Daré’s interpretation of or
conclusions regarding data from clinical studies of its product
candidates; the risk that development of a product candidate
requires more clinical or nonclinical studies than Daré
anticipates; the loss of, or inability to attract, key personnel;
the effects of macroeconomic conditions, geopolitical events,
public health emergencies, and major disruptions in government
operations on Daré’s operations, financial results and condition,
and ability to achieve current plans and objectives; 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;
cybersecurity incidents 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:
Media and Investors on behalf of Daré Bioscience,
Inc:Camilla White / Simona KormanikovaDentons Global
AdvisorsDareBioscience@dentonsglobaladvisors.com /
1.212.466.6450
Source: Daré Bioscience, Inc.
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