Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the publication of a proof of concept
study of DARE-BV1 in Clinical and Experimental Obstetrics &
Gynecology, an international journal focused on publication of high
quality scientific research related to obstetrics and gynecology
and women’s health. DARE-BV1 is a novel thermosetting bioadhesive
hydrogel containing clindamycin phosphate 2% that is being
evaluated as a one-time vaginally administered treatment for
bacterial vaginosis (BV).
The publication, entitled “Proof of concept
study of a novel bioadhesive clindamycin phosphate 2% vaginal gel
to treat bacterial vaginosis,” reported that a single dose of the
study drug, now known as DARE-BV1, administered to 30 patients
diagnosed with bacterial vaginosis showed a meaningful clinical
cure rate of 86% in evaluable patients at the test-of cure visit.
Clinical cure was defined as the resolution of specified clinical
signs and symptoms of bacterial vaginosis that were present at the
time of enrollment in the study.
“This proof of concept study suggests that
DARE-BV1 has the potential to be a highly effective treatment
option for bacterial vaginosis, the most common cause of vaginal
symptoms among women,” said David Friend, PhD, Chief Scientific
Officer of Daré Bioscience. “At the test-of-cure visit 7 to 14 days
after dosing, 86% of the evaluable patients in the study were
clinically cured of their bacterial vaginosis and 96% of those
women remained clinically cured at the follow-up visit 21 to 30
days after dosing. There were no reports of adverse reactions to
DARE-BV1 over the duration of the study.”
Bacterial vaginosis is the leading cause of
vaginitis worldwide and is estimated to affect more than 21 million
women in the United States.1,2 It is estimated that bacterial
vaginosis is present in at least 15% of the sexually active
population3 and is associated with a variety of serious health
issues including preterm birth, pelvic inflammatory disease,
increased susceptibility to sexual transmitted infections
(including HIV), and other chronic health problems.2,4
“Current FDA-approved treatments for the
treatment of bacterial vaginosis offer clinical cure rates ranging
from 37 to 68%,” said Sabrina Martucci Johnson, President and Chief
Executive Officer of Daré Bioscience. “Alarmingly, as many as 50%
of women treated for bacterial vaginosis will experience a
recurrence within 12 months of treatment, which underscores the
need for more effective treatment options for women.” 5
Daré recently announced the initiation of the
DARE-BVFREE study, a multicenter, randomized, double-blind,
placebo-controlled Phase 3 clinical study of DARE-BV1 for the
treatment of 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.
“If DARE-BV1 delivers a similarly high clinical
cure rate in the Phase 3 pivotal study as it did in the pilot
study, we believe DARE-BV1 could become a new front-line treatment
option for women diagnosed with bacterial vaginosis,” said Ms.
Johnson. “Given the anticipated short duration of the Phase 3
study, we expect to report topline data from the study by year-end
2020. Positive results from this single pivotal study will enable
us to submit a new drug application for DARE-BV1 with the FDA in
early 2021, two years from licensing the technology.”
Earlier this year, Daré announced that the U.S.
Food and Drug Administration (FDA) granted Fast Track designation
for DARE-BV1 for the treatment of bacterial vaginosis, in addition
to receiving Qualified Infectious Disease Product (QIDP)
designation for the treatment of bacterial vaginosis in August of
2019.
Fast Track designation is granted by the FDA for
drugs that are intended for the treatment of serious or
life-threatening disease or conditions, which demonstrate the
potential to address an unmet medical need. The designation offers
the opportunity for more frequent interactions with the FDA to
discuss the drug’s development plan and ensure collection of
appropriate data needed to support approval. The Fast Track program
is intended to facilitate development and expedite review of a Fast
Track drug so that an approved product can reach the market
expeditiously.
QIDP designation is available under Title VIII
of the Food and Drug Administration Safety and Innovation Act,
titled Generating Antibiotic Incentives Now (GAIN), which creates
incentives for the development of antibacterial and antifungal drug
products that treat serious or life-threatening infections. The
primary incentive is a five-year exclusivity extension added to any
exclusivity for which a QIDP qualifies upon FDA approval.
The publication entitled “Proof of concept study
of a novel bioadhesive clindamycin phosphate 2% vaginal gel to
treat bacterial vaginosis” is currently available in the Latest
Articles section on the journal’s website, or at
https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.04.5304.
- Clinical Infectious Diseases
2007; 44:213–9; https://doi.org/10.1086/509577
- Centers for Disease Control and
Prevention, Bacterial Vaginosis (BV) Statistics, viewed at
https://www.cdc.gov/std/bv/stats.htm
- Clinical Infectious Diseases 2007;
44:220–1;https://doi.org/10.1086/509584
- Onderdonk, A. et al. “The Human
Microbiome during Bacterial Vaginosis,” Clinical Microbiology
Reviews, April 2016 Volume 29 Number 2
- 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 clinical-stage 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, the potential for
DARE-BV1 to demonstrate a higher clinical cure rate than current
FDA-approved drug products and become a front-line treatment option
for bacterial vaginosis, the timing of availability of topline
results of the DARE-BVFREE study and submission of a new drug
application for DARE-BV1, 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
and QIDP designations 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
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
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.
Contact:
Investors on behalf of Daré Bioscience, Inc.:Lee RothBurns
McClellanlroth@burnsmc.com212-213-0006
Source: Daré Bioscience, Inc.
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