Daré Bioscience, Inc.
(NASDAQ: DARE), a leader in clinical-stage women’s health
innovation, today announced that it is currently enrolling patients
in an investigational study designed to evaluate the feasibility of
using thermography technology to assess the pharmacodynamics of
Sildenafil Cream, 3.6% in normal healthy women. Sildenafil, the
active ingredient in Sildenafil Cream, 3.6%, is marketed in an oral
dosage form under the brand name Viagra® for the treatment of
erectile dysfunction in men. Daré Bioscience, in partnership
with Strategic Science & Technologies, LLC (SST), is developing
Sildenafil Cream, 3.6% as a potential treatment for female sexual
arousal disorder (FSAD). During the thermography study, genital
temperature, a surrogate for genital blood flow, will be captured
and recorded utilizing an infrared camera capable of detecting heat
patterns from blood flow in body tissues. The study consists of the
screening visit (visit 1), the double-blind dosing of placebo or
active cream (visits 2-3) and a safety follow-up.
“We are excited to announce that enrollment is
underway in this thermography study,” said Sabrina Martucci
Johnson, President & CEO of Daré Bioscience. “This study is
part of our larger FSAD development program, and reflects
capital-efficient activities we are pursuing to enrich and enhance
the Phase 2b program. This small exploratory study has the
potential to provide greater insight into the physiologic activity
and time to effect resulting from the application of Sildenafil
Cream, 3.6% externally to the vulva and internally in the vagina,
which would further inform and support the design of our Phase 2b
at-home study, anticipated to commence in 2019.”
Sildenafil Cream, 3.6% is a proprietary cream
formulation specifically designed to increase blood flow to the
genital tissue in women, leading to a potential improvement in
genital arousal response during sexual activity. If successful,
Sildenafil Cream, 3.6% has the potential to be the first
FDA-approved FSAD treatment option.
“The thermography study is part of a comprehensive
clinical development and regulatory strategy that includes an
upcoming content validity study to support the implementation of
FSAD specific patient reported outcome (PRO) instruments, as well
as an at-home dosing study which together constitute our Phase 2b
program,” said Mary Jarosz, Global Head of Regulatory Affairs for
Daré Bioscience.
The principal investigator for the thermography
study is Dr. Irwin Goldstein, 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 pleased
to be working with SST and Daré on the Sildenafil Cream, 3.6%
program, leveraging the known therapeutic benefit of Viagra® to
stimulate increased blood flow to the genital tissue,” said Dr.
Goldstein. “There are no approved drugs for the treatment of FSAD
and Sildenafil Cream, 3.6% has the potential to be an on-demand
solution to prepare the body for a more pleasurable sexual
experience.”
About Sildenafil Cream, 3.6% and 3Q2018
Type C Meeting with the FDA
Sildenafil Cream, 3.6% has the potential to be the
first FDA-approved FSAD treatment option. Unlike other female
sexual disorders, FSAD is characterized primarily by an inability
to attain or maintain sufficient physical sexual arousal that
causes distress or interpersonal difficulty. It is the closest
analog in women to erectile dysfunction in men. While increased
attention has been focused on female sexual dysfunction over the
past several years, no pharmacologic options have yet been U.S.
Food and Drug Administration (FDA) approved for FSAD. In a Phase 2a
trial, Sildenafil Cream, 3.6% increased measurable blood flow to
the vaginal tissue in both pre- and postmenopausal women with FSAD
compared to placebo.
During the third quarter of 2018, we had a Type C
meeting with the FDA regarding the Phase 2b program for Sildenafil
Cream, 3.6%. The objective of this meeting was to align with the
agency on key aspects of the Phase 2b and the overall clinical
program to support the planned New Drug Application, or NDA,
including the screening assessments used to accurately diagnose
FSAD, the PRO instruments to be used as primary efficacy endpoints
for pivotal clinical studies, study duration, and the target
patient population to be studied.
Based on the outcome of this meeting, in the fourth
quarter of 2018, we will commence Phase 2b related activities for
Sildenafil Cream, 3.6% with the initiation of a content validity
PRO study to demonstrate that the FSAD symptoms we plan to assess
in our Phase 2b and our pivotal studies are the most important and
relevant to our target patient population and are also acceptable
efficacy endpoints for the FDA. After the content validity PRO
study is completed and before the Phase 2b at-home trial is
initiated, we plan to request another Type C meeting to obtain the
FDA’s guidance on whether it agrees that the PRO instruments are
content valid for the target population.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s reproductive and sexual health. The
company’s mission is to identify, develop and bring to market a
portfolio of novel, differentiated therapies that expand treatment
options, improve outcomes and facilitate convenience for women in
the areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s product portfolio includes two potential
first-in-class candidates in clinical development: Ovaprene®, a
non-hormonal, monthly contraceptive vaginal ring, and Sildenafil
Cream, 3.6%, a potential treatment for female sexual arousal
disorder utilizing the same active ingredient as Viagra®. To learn
more about Daré’s full portfolio of women’s health products, and
mission to deliver novel 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 uses these channels to
communicate with its investors and the public about the company and
other company-related matters. The information Daré posts on its
investor relations website 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.
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, the timing of initiation or
completion of the company’s clinical studies, and the company’s
ability to advance its product candidates through clinical
development and regulatory approval. 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: our ability to raise additional capital
when and as needed; our ability to develop and commercialize our
product candidates; the failure or delay in starting, conducting
and completing clinical trials or obtaining FDA or foreign
regulatory approval for our product candidates in a timely manner;
our 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 efficacy of our
product candidates; our ability to retain our licensed rights to
develop and commercialize a product candidate; our ability to
satisfy the monetary obligations and other requirements in
connection with our exclusive, in-license agreements covering the
critical patents and related intellectual property related to our
product candidates; developments by our competitors that make our
product candidates less competitive or obsolete; our dependence on
third parties to conduct clinical trials; our ability to adequately
protect or enforce our, or our licensor’s, intellectual property
rights; the lack of patent protection for the active ingredients in
certain of our product candidates which could expose our 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 our
intellectual property rights. Our forward-looking statements are
based upon our 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 our risks and uncertainties, you are encouraged to review our
documents filed with the SEC including our 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.:
Ami Bavishi Burns McClellan abavishi@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:
Amanda Guisbond Canale Communications amanda@canalecomm.com
781-405-8775
Source: Daré Bioscience, Inc.
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