Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced its participation in the Women’s
Health Case Study: Optimizing Study Enrollment During the COVID-19
Pandemic panel at the Women’s Innovation Summit being held in
Boston, MA, September 14 – 15, 2021, at The Westin Copley Place.
“The COVID-19 pandemic presented many challenges
for clinical trials, especially around site selection, recruitment
and enrollment of patients. We had to take a step back and
reconsider study design, as well as how we would enroll patients
and complete check-up visits,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “In 2020, we worked closely
with our CRO for the study, Health Decisions, to successfully
initiate and complete a Phase 3 study of our drug candidate
DARE-BV1 for the treatment of bacterial vaginosis. I’m excited to
join Dr. Mary Gunn of Health Decisions to share our insights on how
we successfully enrolled our study and did so more quickly than
initially anticipated, despite launching after the COVID-19
pandemic shut down of non-essential operations across the United
States.”
|
Panel
Details: |
Event: |
Women’s Health Innovation Summit |
Panel: |
Women’s Health Case Study:
Optimizing Study Enrollment During the Covid-19 Pandemic |
Date: |
Tuesday, September 14, 2021 |
Time: |
12:00 p.m. EST / 9:00 a.m.
PST |
Participants: |
Sabrina Martucci Johnson,
President and CEO, Daré BioscienceDr. Mary Gunn, Chief Operating
Officer, Health Decisions |
|
|
Additional information about the 2021 Women’s
Health Innovation Summit is available at
https://womenshealthinnovationusa.com/.
About DARE-BV1 and the DARE-BVFREE Phase
3 Study
DARE-BV1 is an investigational thermosetting
bioadhesive hydrogel containing clindamycin phosphate 2% designed
as a one-time vaginally-administered treatment for bacterial
vaginosis. The DARE-BVFREE Phase 3 study was a double-blinded
clinical trial that randomized 307 women diagnosed with bacterial
vaginosis at 32 centers across the U.S. in a 2:1 ratio to receive a
single vaginal dose of DARE-BV1 (clindamycin phosphate vaginal gel,
2%) or a single vaginal dose of placebo gel. The study met its
primary endpoint, demonstrating that a single administration of
DARE-BV1 was superior to placebo as a primary therapeutic
intervention for women diagnosed with bacterial vaginosis, and the
study results support DARE-BV1’s potential to improve outcomes and
convenience for women. A single dose of DARE-BV1 achieved clinical
cure rates of 70-81% in the study. Clinical cure rates of current
FDA-approved products for the treatment of bacterial vaginosis
range from 37-68%. Daré submitted a new drug application (NDA) to
the U. S. Food and Drug Administration (FDA) for DARE-BV1 for the
treatment of bacterial vaginosis earlier this year. The FDA granted
the NDA Priority Review and set a Prescription Drug User Fee Act
(PDUFA) date of December 7, 2021 for the target completion of its
review of the NDA.
More information about the DARE-BVFREE Phase 3
study can be found in the company’s most recent investor
presentation under “Presentations, Events & Webcasts" in the
Investors section of the company's website at
http://ir.darebioscience.com.
About Bacterial Vaginosis
Bacterial vaginosis is the most common vaginal
condition in women ages 15 – 44 and can cause serious health risks
and very disruptive symptoms. Bacterial vaginosis is estimated to
affect approximately 21 million women in the United States.
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 proprietary 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 regarding
DARE-BV1’s clinical cure potential for bacterial vaginosis,
DARE-BV1’s potential to provide more effective and convenient
treatment for bacterial vaginosis as compared to current
FDA-approved products for the treatment of bacterial vaginosis, and
DARE-BV1’s commercial potential. 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: the risk that the FDA, other regulatory
authorities or members of the scientific or medical communities may
not accept or agree with Daré’s interpretation of or conclusions
regarding the data from the DARE-BVFREE clinical study and/or may
require additional clinical or nonclinical studies of DARE-BV1
prior to approving the NDA; whether and when the NDA for DARE-BV1
pending with the FDA may be approved, which will depend on a
variety of factors, including making a determination as to whether
the product's benefits outweigh its known risks and determination
of the product's efficacy and, if approved, whether DARE-BV1 will
be commercially successful; decisions by the FDA impacting
labeling, manufacturing processes, safety and/or other matters that
could affect the availability or commercial potential of DARE-BV1;
Daré’s failure to timely establish or leverage third-party
partnerships or collaborations to commercialize its product
candidates, if approved; 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 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.
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
Source: Daré Bioscience, Inc.
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Jul 2023 to Jul 2024