Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced topline data from its Phase 1/2
clinical study of DARE-VVA1, a novel intravaginal proprietary
formulation of tamoxifen being developed for the treatment of
moderate to severe vulvar and vaginal atrophy. The randomized,
double-blind, placebo-controlled study was designed to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
DARE-VVA1 in postmenopausal participants with moderate to severe
VVA. The topline data from the study demonstrated safety and
tolerability of DARE-VVA1, as well as improvement in the vaginal
cytology parameters and the bothersome vaginal symptoms associated
with VVA. DARE-VVA1 has the potential to be the first therapeutic
specifically approved for the treatment of VVA in U.S. patients
with HR+ breast cancer. There are currently no FDA-approved
products labeled for VVA treatment in HR+ breast cancer patients.
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%.
“There is a clear unmet need for an effective
non-hormonal treatment for VVA caused by anti-cancer endocrine
therapy in patients diagnosed with HR+ breast cancer. Commonly,
estrogen-based therapies delivered through creams, intravaginal
rings, and vaginal suppositories are prescribed for the treatment
of VVA symptoms. However, the use of estrogen-based products for
the treatment of VVA in HR+ breast cancer patients can be
challenging for both healthcare providers and their patients as the
use of estrogen products, in any form, is often contraindicated for
this patient population,” said Sabrina Martucci Johnson, President
and Chief Executive Officer of Daré Bioscience. “If we are
successful, vaginally-administered DARE-VVA1 has the potential to
become a new standard of care as the first and only product
approved in the U.S. for the treatment of VVA specifically in an
HR+ breast cancer patient population.”
“We are highly encouraged by the positive
topline results of the Phase 1/2 study of DARE-VVA1 as this study
is a critical step in developing a potential non-hormonal treatment
alternative for VVA,” said Dr. Annie Thurman, Medical Director of
Daré Bioscience. “The symptoms of VVA adversely impact quality of
life for women, particularly women also undergoing HR+ breast
cancer treatment and management.”
DARE-VVA1 Phase 1/2 Clinical Trial Study
Design
The Phase 1/2 study evaluated different doses of
DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women
with VVA. The study was a randomized, multi-center, double-blind,
parallel-arm, placebo-controlled, dose-ranging study that evaluated
the safety, tolerability, plasma pharmacokinetics (PK) and
pharmacodynamics (PD) of DARE-VVA1. Eligible participants were
randomly allocated to one of five treatment groups (approximately 4
participants per group) that evaluated four dose levels
(1 mg, 5 mg, 10 mg, and 20 mg) and a placebo.
Following a screening visit, DARE-VVA1 was 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 had serial
blood sampling for PK analysis and underwent safety evaluations and
preliminary assessments of effectiveness. Following the completion
of the treatment period, participants attended a safety follow-up
visit.
The primary endpoints of the study evaluated the
safety and tolerability of DARE-VVA1 by vaginal administration and
determined the plasma PK of DARE-VVA1 after intravaginal
application. Secondary endpoints evaluated preliminary efficacy and
PD of DARE-VVA1 in terms of most bothersome vaginal symptom and
changes in vaginal cytology and pH.
The study was conducted by the company’s wholly
owned subsidiary in Australia.
Topline Results of the Phase 1/2
Clinical Trial
The age of the 17 postmenopausal women with VVA
who participated in the study ranged from 49 to 68 years (average
age: 60.9). Fourteen women completed the study.
The primary outcomes of this first-in-woman
study were safety and plasma PK. Intravaginal administration of
DARE-VVA1 was well tolerated and all treatment emergent adverse
events were mild or moderate and equally distributed between
participants randomized to study drug treatment versus placebo.
Concentration of tamoxifen in plasma samples collected over the
course of the study did not exceed 10 ng/mL, even in participants
in the highest dose group (20 mg), which is 1/10th of the average
steady-state concentration of tamoxifen seen with daily dosing of
orally administered tamoxifen citrate tablets (20 mg and 10 mg
tamoxifen) for three months (average steady-state plasma
concentrations of over 100 ng/mL). Secondary outcomes of the study
were preliminary efficacy and PD of DARE-VVA1 in terms of most
bothersome vaginal symptom and changes in vaginal cytology and pH.
Participants who received study drug treatment (at 1 mg, 5 mg, 10
mg or 20 mg doses) had improvements in the assessments and symptoms
associated with VVA – specifically, they had decreases in vaginal
pH, increases in the percentage of vaginal superficial cells,
significant (p=0.04) decreases in the percentage of vaginal
parabasal cells (despite the small sample size), and reduction in
their self-assessed most bothersome vaginal symptom reported
(either vaginal dryness or pain with intercourse).
Regarding the most bothersome vaginal symptom
reported, of the participants randomized to receive study drug
treatment, 39% (5/13) reported that vaginal dryness and 62% (8/13)
reported that pain with intercourse (dyspareunia) was their most
bothersome vaginal symptom at baseline. At the end of the treatment
period, among the participants randomized to receive study drug
treatment who reported vaginal dryness as their most bothersome
symptom at baseline (n=5) (moderate or severe), all those who
completed the study reported that vaginal dryness was either absent
(n=1) or mild (n=3). Among the participants randomized to receive
study drug treatment who reported dyspareunia as their most
bothersome symptom at baseline (n=8) (moderate or severe), at the
end of the treatment period, four reported no longer experiencing
dyspareunia, one reported mild dyspareunia, two had no change in
this symptom, and one did not complete the study. Of the four
participants randomized to the placebo group, two reported vaginal
dryness and two reported dyspareunia as their most bothersome
symptom at baseline. At the end of the treatment period, the
participants randomized to the placebo group who reported vaginal
dryness as their most bothersome symptom at baseline (n=2)
(moderate or severe), reported that vaginal dryness was either
absent (n=1) or mild (n=1), and among the participants randomized
to the placebo group who reported dyspareunia as their most
bothersome symptom at baseline (n=2), one reported no longer
experiencing dyspareunia and one did not complete the study.
Daré plans to submit data from the Phase 1/2
clinical study of DARE-VVA1 for publication in a peer-reviewed
publication.
Following clinical development, Daré intends to
leverage the existing safety and efficacy data on the active
ingredient in DARE-VVA1, tamoxifen, to utilize the U.S. Food and
Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing
approval of DARE-VVA1 in the U.S.
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, 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.
Products containing estrogen are commonly used
to treat VVA. However, the use of estrogen-containing products for
the treatment of VVA is often contraindicated for HR+ breast cancer
patients and survivors because of the concern that estrogen use
will promote recurrence of disease.
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 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,
fertility, and vaginal and sexual health.
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 hormone therapy
following menopause. 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 become a new standard of care as the first
FDA-approved product for the treatment of VVA specifically in an
HR+ breast cancer patient population, the importance of the Phase
1/2 clinical study results to Daré and DARE-VVA1, and the
anticipated regulatory approval pathway for 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 those expressed or implied by the forward-looking statements
in this press release, including, without limitation: 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; 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; 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; 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 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 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 RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience,
Inc.:Jake RobisonEvoke
Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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