Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the publication of results of its Phase
1/2 clinical study of DARE-VVA1, a proprietary, investigational
formulation of tamoxifen for intravaginal administration to treat
vulvovaginal atrophy (VVA) in women without the use of hormones.
The journal article, “Pharmacokinetics, safety and preliminary
pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule
containing tamoxifen for the treatment of vulvovaginal atrophy,”
was published online and will appear in Climacteric, the official
journal of the International Menopause Society. The randomized,
double-blind, placebo-controlled study was designed to evaluate the
pharmacokinetics, safety and pharmacodynamics of DARE-VVA1 in
postmenopausal participants with moderate to severe VVA.
“We are excited to have this peer-reviewed article published in
the International Menopause Society’s journal, Climacteric, and
share our findings with the broader women’s health community,” said
Andrea Thurman, MD, Medical Director for Daré Bioscience and lead
author of the journal article. “The data from the study
demonstrated safety and tolerability of our investigational product
DARE-VVA1, as well as showed an improvement in vaginal cytology
parameters and the bothersome vaginal symptoms commonly associated
with VVA.”
Daré is developing DARE-VVA1 as a new hormone-free treatment
option to address moderate to severe VVA. If successful, DARE-VVA1
has the potential to be an important therapeutic for the treatment
of VVA for women currently or previously treated for
hormone-receptor positive (HR+) breast cancer and for other women
who would like a vaginal, non-hormonal option for VVA
treatment.
Globally, breast cancer is the most frequently diagnosed cancer
type, accounting for over two million cases each year.
Approximately 4 million U.S. women have a history of invasive
breast cancer, and of all breast cancer diagnoses in U.S. women, it
is estimated that more than 68% are HR+. VVA prevalence in
postmenopausal breast cancer survivors is estimated at 42% to
70%.
“The unmet need for an effective non-hormonal treatment for VVA
caused by anti-cancer endocrine therapy in patients diagnosed with
HR+ breast cancer is undeniable. The current lineup of
estrogen-based therapies, commonly used to treat VVA in non-cancer
patients, can be challenging for both HR+ breast cancer patients
and their providers as the use of estrogen products, in any form,
is often contraindicated for the HR+ breast cancer patient
population,” said Sabrina Martucci Johnson, President and Chief
Executive Officer of Daré Bioscience. “If we are successful,
vaginally-administered, hormone-free DARE-VVA1 will offer patients
and providers an important new treatment option to address one of
the most common vaginal side effects associated with breast cancer
therapy.”
The journal article is available online:
https://doi.org/10.1080/13697137.2023.2211763
In November 2022, Daré announced positive topline results from
the Phase 1/2 clinical study of DARE-VVA1.
Daré is conducting activities to support submission of an
Investigational New Drug (IND) application and initiation of a
Phase 2 clinical study of DARE-VVA1.
About Vulvovaginal Atrophy (VVA)
VVA is an inflammation and thinning of the vaginal epithelium
due to the reduction in levels of circulating estrogen. Typical
symptoms include vaginal dryness, itching, burning, and painful
intercourse, adversely impacting quality of life. VVA is a common
condition in postmenopausal women and women with, or with a history
of, HR+ breast cancer. Many breast cancer survivors experience
menopausal symptoms irrespective of age as a direct consequence of
their cancer treatment. Breast cancer patients treated with
aromatase inhibitors refer to VVA as one of the most unpleasant
side effects of treatment. The prevalence of VVA in postmenopausal
breast cancer patients is estimated to be between 42 and 70
percent.
Commonly used therapies for VVA are estrogen based and are often
contraindicated in HR+ breast cancer patients, or patients with a
genetic predisposition or history of familial disease, because of
the concern that estrogen use will promote recurrence or occurrence
of disease.
About DARE-VVA1
DARE-VVA1 is an investigational, proprietary formulation of
tamoxifen for intravaginal administration. Daré is developing
DARE-VVA1 as a hormone-free alternative to estrogen-based therapies
for the treatment of moderate to severe VVA. Tamoxifen is a
well-known and well-characterized selective estrogen receptor
modulator (SERM) that has been prescribed by oncologists for
decades for the treatment of breast cancer. Tamoxifen has unique
properties that produce different effects (estrogen agonist or
estrogen antagonist) in different types of tissues. In breast
tissue, tamoxifen acts as an estrogen antagonist, meaning that it
can inhibit estrogen's effect and hence why it may be effective in
treating HR+ breast cancer. In contrast, in other tissues such as
vaginal tissues, tamoxifen has been reported to elicit an
estrogen-like response. This has the potential to have a favorable
effect on vaginal cytology. Studies of tamoxifen conducted over the
last 40 years have documented its estrogen-like effects on vaginal
epithelium. Localized tamoxifen therapy such as DARE-VVA1 thus has
the potential to counter the physiologic changes that lead to VVA
without introducing estrogen back into the system.
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 DARE-VVA1’s potential as a safe and
effective therapy for VVA, DARE-VVA1’s potential to be a VVA
treatment option for the HR+ breast cancer population, the
potential market opportunity for DARE-VVA1, the importance of the
results of the Phase 1/2 clinical study to Daré and DARE-VVA1, and
the anticipated regulatory approval pathway and next steps for
development of DARE-VVA1. 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 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 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 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 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 impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; 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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