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 the completion of a content validity study, a
non-interventional study integral to initiating the at-home,
product dosing portion of the Sildenafil Cream, 3.6% (Sildenafil
Cream) Phase 2b program. Daré plans to review the findings of the
content validity study with the U.S. Food and Drug Administration
(FDA) in a Type C meeting and to seek alignment on the patient
reported outcome (PRO) instruments to be used to screen eligible
patients with Female Sexual Arousal Disorder (FSAD) and to assess
the efficacy of Sildenafil Cream in treating FSAD.
“Since there are no products yet approved by the
FDA for the FSAD indication, we believe the data we collected are
truly groundbreaking,” said Sabrina Martucci Johnson, President and
CEO of Daré Bioscience. “We look forward to meeting with the FDA
later this year, and presenting the rigor that went into the study
and the data collected. Our intent is to utilize our findings to
formulate a PRO efficacy endpoint and screening strategy designed
specifically for FSAD, with the goal of commencing our Phase 2b
study before the end of 2019.”
The content validity study was designed to
demonstrate that women clinically diagnosed with FSAD can
understand the items, instructions and response options of the
proposed PRO instruments (specifically those questions focused on
genital arousal) and to confirm that the content within the PRO
instruments captures the most important and relevant symptoms of
FSAD patients. Participants who met the eligibility criteria
participated in one-on-one, in-depth interviews conducted by
subject matter experts in the field of clinical outcome assessments
and female sexual medicine. Pending alignment with the FDA, the
data from this non-interventional study is intended to be used as
the basis to identify and screen women with FSAD in the Phase 2b
and Phase 3 studies, as well as to evaluate their response to the
investigational product, Sildenafil Cream.
Of the various types of female sexual
dysfunction disorders, FSAD is most analogous to erectile
dysfunction (ED) in men and is characterized primarily by an
inability to attain or maintain sufficient genital arousal during
sexual activity that causes distress or interpersonal difficulty.
Despite a number of approved prescription products for ED, no
pharmacologic options have yet been approved by the FDA for FSAD.
Sildenafil, the active ingredient in Sildenafil Cream, is marketed
in an oral dosage form under the brand name Viagra® for the
treatment of ED in men.
Sildenafil Cream is a proprietary cream
formulation of sildenafil 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 in clinical studies, Sildenafil Cream has the potential
to be the first FDA-approved pharmacologic treatment option for
FSAD. In a Phase 2a trial, Sildenafil Cream increased measurable
blood flow to the vaginal tissue in both pre- and post-menopausal
women with FSAD compared to placebo cream. Further, data from a
thermography study in healthy women demonstrated significantly
greater increases in genital temperature after administration of
Sildenafil Cream compared to after administration of placebo cream
as well as no cream at all, indicating a positive impact on genital
blood flow during the 30-minute testing session.
“The completion of the content validity study is
a critical milestone toward advancing into the Phase 2b and Phase 3
stages of the development plan,” said Steven Brugger, President and
Chief Operating Officer of SST. “We are excited to be working at
the cutting edge of research focused on women’s sexual health and
to advance a potential first-in-category treatment option for women
suffering with FSAD.”
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; 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 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: www.darebioscience.com.
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
treat FSAD, the potential of Sildenafil Cream to be the first
FDA-approved product for FSAD, the usefulness of the content
validity study to the clinical development and potential regulatory
approval of Sildenafil Cream, and the timing of development
milestones for Sildenafil Cream. 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;
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; 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 RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonCanale Communicationsjake@canalecomm.com619.849.5383
Source: Daré Bioscience
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