Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the initiation of the DARE-BVFREE
study, a multi-center, double-blind, placebo-controlled Phase 3
clinical study of DARE-BV1 for the treatment of bacterial
vaginosis.
DARE-BV1 is an investigational thermosetting bioadhesive
hydrogel containing clindamycin phosphate 2% being evaluated as a
one-time, vaginally-administered treatment for bacterial vaginosis.
The DARE-BVFREE study is expected to enroll approximately 240
participants, ages 12 and older, diagnosed with bacterial vaginosis
across multiple clinical sites in the United States. The primary
endpoint is clinical cure of bacterial vaginosis, defined as
resolution of specified clinical signs and symptoms, at the
test-of-cure visit to occur 21 to 30 days after enrollment in the
study. The total study duration will be approximately one
month for each individual participant.
“The initiation of the DARE-BVFREE study is a critical milestone
for Daré as we advance our portfolio of novel women’s health
programs to meaningful value inflection points,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “We worked
closely with our study investigators to achieve commencement of
this pivotal study on our previously communicated timeline, despite
disruptions related to the COVID-19 pandemic, and we continue to
anticipate reporting topline data in 2020. If this single
Phase 3 study is successful, we intend to file a new drug
application with the FDA for DARE-BV1 in 2021.”
DARE-BV1 has received both Fast Track and Qualified Infectious
Disease Product designations from the FDA for the treatment of
bacterial vaginosis. Fast track is a process designed to facilitate
the development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. Fast Track designation
for DARE-BV1 underscores that bacterial vaginosis is a serious
infection for which current treatment options are inadequate.
“DARE-BV1 demonstrated an 86% clinical cure rate in evaluable
subjects at the test-of-cure visit that occurred 7 to 14 days after
a single administration in an investigator-initiated proof of
concept study,” said David Friend, PhD, Chief Scientific Officer
for Daré Bioscience. “If DARE-BV1 delivers a similarly high
clinical cure rate in the Phase 3 pivotal study, we believe
DARE-BV1 could become a new front-line treatment option for women
diagnosed with bacterial vaginosis.”
Bacterial vaginosis is estimated to effect more than 21 million
women in the United States,1 and with clinical cure rates ranging
from 37 to 68%, currently available FDA-approved treatment options
are insufficient for many women. Less than optimal clinical cure
rates may also be a key driver of the high rate of recurrence of
bacterial vaginosis. It is estimated that as many as 50% of women
treated for bacterial vaginosis will experience a recurrence within
12 months of their treatment.2
The DARE-BVFREE study is a multicenter, randomized,
double-blind, placebo-controlled study of DARE-BV1 (clindamycin
phosphate vaginal gel, 2%) compared to placebo vaginal gel for the
treatment of bacterial vaginosis. Patients will be evaluated at
three time points: a Day 1 Screening/Randomization visit, a Day
7-14 Interim Assessment visit, and a Day 21-30 Test of Cure
visit.
Trial design details can be found at ClinicalTrials.gov, study
ID: NCT04370548, or
https://clinicaltrials.gov/ct2/show/NCT04370548.
- Centers for Disease Control and Prevention, Bacterial Vaginosis
(BV) Statistics, viewed at
https://www.cdc.gov/std/bv/stats.htm
- The Journal of Infectious Diseases 2006; 193:1478–86;
https://www.ncbi.nlm.nih.gov/pubmed/16652274
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 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 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
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 on its investor relations website
(https://darebioscience.gcs-web.com/) 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. Such statements
include, but are not limited to, the potential of a single
administration of DARE-BV1 to safely and effectively treat
bacterial vaginosis (BV), the potential for DARE-BV1 to demonstrate
a higher clinical cure rate than current FDA-approved BV treatments
and become a front-line treatment option for BV, the timing of
availability of topline results of the DARE-BVFREE study, the
potential for regulatory approval of DARE-BV1 based on a single,
successful Phase 3 clinical study, namely the DARE-BVFREE study,
and the significance of Fast Track designation for the DARE-BV1
program. 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 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 U.S. Food and Drug
Administration (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; 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 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.
Daré Bioscience, Inc.
Investors on behalf of Daré Bioscience, Inc.:Lee Roth Burns
McClellanEmail: lroth@burnsmc.com +1 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake Robison
Canale CommunicationsEmail: jake@canalecomm.com+1
619-849-5383
Source: Daré Bioscience, Inc.
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