Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced the initiation of a Phase 1/2
clinical study of DARE-VVA1, a novel intravaginal tamoxifen product
being developed for the treatment of moderate to severe vulvar and
vaginal atrophy (VVA). The randomized, double-blind,
placebo-controlled study is designed to evaluate the safety,
pharmacokinetics and pharmacodynamics of DARE-VVA1 in
postmenopausal participants with moderate to severe VVA and is
being conducted by the company’s wholly owned subsidiary in
Australia.
“Vulvar and vaginal atrophy is an inflammation
of the vaginal epithelium associated with lower estrogen levels as
a result of menopause and certain cancer treatments and its
symptoms adversely impact quality of life for women. Today,
therapies for VVA are predominantly based on estrogen; however,
there is a large unmet need for a novel non-hormonal VVA treatment
specifically developed for women who have VVA as a result of
treatment for hormone receptor-positive breast cancer, as well as
for other women, who require or prefer a treatment option for VVA
that does not contain estrogen,” said Sabrina Martucci Johnson,
Daré’s President and Chief Executive Officer. “We’re encouraged by
an exploratory study of intravaginally administered tamoxifen
published in Clinical and Experimental Obstetrics and Gynecology ,
that demonstrated improvements in vaginal pH and vaginal dryness
without significant systemic absorption of tamoxifen in
postmenopausal women with VVA,1 together with studies of tamoxifen
conducted over the last 40 years that have documented its
estrogen-like effects on the vaginal epithelium. We’re excited for
the clinical advancement of DARE-VVA1 as a potential non-hormonal
treatment alternative for this population.”
The Phase 1/2 study will evaluate different
doses of DARE-VVA1, a tamoxifen vaginal insert, in approximately 40
postmenopausal women with VVA, including a cohort of women with a
history of breast cancer. The study is a randomized, multi-center,
double-blind, parallel-arm, placebo-controlled, dose‑ranging study
that will evaluate the safety, tolerability, plasma
pharmacokinetics (PK) and pharmacodynamics (PD) of DARE‑VVA1.
Eligible participants will be randomly allocated to one of five
treatment groups (approximately 8 participants per group) that will
evaluate four dose levels (1 mg, 5 mg, 10 mg,
and 20 mg) and a placebo. Following a screening visit,
DARE‑VVA1 will be self-administered intravaginally once a day for
the first two weeks, and then twice a week for the following six
weeks for a total treatment period of 56 days. In each
treatment group, participants will have serial blood sampling for
PK analysis and undergo safety evaluations and preliminary
assessments of effectiveness. Following the completion of the
treatment period, participants will attend a safety follow-up
visit.
The primary endpoints of the study will evaluate
the safety and tolerability of DARE-VVA1 by vaginal administration
and determine the plasma PK of DARE-VVA1 after intravaginal
application. Secondary endpoints will evaluate preliminary efficacy
and PD of DARE-VVA1 in terms of most bothersome symptom and changes
in vaginal cytology and pH.
“Women navigating breast cancer treatment face
many challenges and hardships in addition to those we commonly
think about, including VVA,” said James A. Simon, MD, CCD, NCMP,
IF, FACOG, Clinical Professor of Obstetrics and Gynecology at The
Washington University School of Medicine, and Medical Director and
Founder of IntimMedicine Specialists®. “Having a safe and
effective, non-hormonal therapy to address the uncomfortable
symptoms of VVA could offer both physical and psychological
benefits to patients and survivors. I look forward to following the
progression of DARE-VVA1 as a potential first-in-category
hormone-free vaginal treatment for VVA.”
About Vulvar and Vaginal 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, hormone receptor-positive (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.2 Approximately 10 percent of women in the U.S. will
develop breast cancer. The prevalence of VVA in postmenopausal
breast cancer patients is estimated to be between 42 and 70
percent.
Products containing estrogen are commonly used
to treat VVA. However, the use of estrogen-containing products for
the treatment of VVA may be contraindicated for HR+ breast cancer
patients and survivors because of the concern that estrogen use
will promote recurrence of disease.3
About DARE-VVA1
DARE-VVA1 is an investigational, proprietary
formulation of tamoxifen for intravaginal administration with the
potential to be a first-in-category treatment of VVA for women with
or at-risk of HR+ breast cancer. 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. In breast tissue, tamoxifen acts as an
estrogen antagonist. In contrast, in other tissues such as vaginal
tissues, tamoxifen has been reported to exert an estrogen-like
response 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 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
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®; 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 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 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 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 on
the investor relations page of Daré’s website mentioned above.
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. In this press release, forward-looking
statements include, but are not limited to, statements relating to
the conduct of Phase 1/2 clinical study of DARE-VVA1 and
DARE-VVA1’s potential as a safe and effective therapy for VVA,
including for HR+ breast cancer patients and survivors.
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 and continue as a going concern; the
effects of the COVID-19 pandemic 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, including its
clinical trials, to fulfill their contractual obligations to Daré;
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 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; 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 developments
by competitors make Daré’s product candidates less competitive or
obsolete; failure of Daré’s product candidates, if approved, to
gain market acceptance or obtain adequate coverage from third-party
payers; 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;
Daré’s failure to timely establish or leverage third-party
partnerships or collaborations to commercialize its product
candidates, if approved; 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; 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.
Footnotes:
1 J. Chollet, L. A. Meyn, F. Mermelstein. Weekly
vaginal administration of tamoxifen for three months in
postmenopausal women with vulvar and vaginal atrophy: a possible
new treatment approach?. Clinical and Experimental Obstetrics &
Gynecology, 2019, 46(2): 285-288. DOI: 10.12891/ceog4948.2019
2 Biglia N., Bounous V.E., D’Alonzo M., Ottino
L., Tuninetti V., et al. Vaginal Atrophy in Breast Cancer
Survivors: Attitude and Approaches Among Oncologists. Clin. Breast
Cancer, 2017 Dec; 17(8):611-17. DOI:
https://doi.org/10.1016/j.clbc.2017.05.008
3 American College of Obstetricians and
Gynecologists’ Committee on Gynecologic Practice. The Use of
Vaginal Estrogen in Women With a History of Estrogen-Dependent
Breast Cancer. Committee Opinion No. 659, March 2016 (Reaffirmed
2020).
https://www.acog.org/-/media/project/acog/acogorg/clinical/files/committee-opinion/articles/2016/03/the-use-of-vaginal-estrogen-in-women-with-a-history-of-estrogen-dependent-breast-cancer.pdf
Contacts:
Investors on behalf of Daré Bioscience,
Inc.:Lisa Walters-Hoffert, Chief Financial OfficerDaré Bioscience,
Inc.lwalters@darebioscience.com 858.926.7655
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake.robison@canalecomm.com 619.849.5383
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