Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the presentation of a poster at the
upcoming annual meeting of the Infectious Diseases Society for
Obstetrics and Gynecology taking place August 8-10, 2019 in Big
Sky, Montana. The poster presentation will highlight the results of
an investigator-initiated, proof of concept study of DARE-BV1, a
novel thermosetting bioadhesive vaginal gel technology containing
clindamycin phosphate 2% for the treatment of bacterial vaginosis
(BV).
“In the study, DARE-BV1 achieved a clinical cure rate of 86% at
the test-of-cure endpoint, well above currently Food and Drug
Administration approved treatments for BV, with clinical cure rates
that range from 37-68%,” said Dr. David Friend, Daré’s Chief
Scientific Officer. “We’re excited to share these findings with the
scientific and medical community as we believe that DARE-BV1 has
the potential to be an important new option for the estimated 21
million women in the U.S. affected with BV.”
BV is the most common vaginal infection in women ages 15-44.1 BV
is characterized by a shift in the vaginal flora from the dominant
Lactobacillus to a polymicrobial flora.2 BV has been
associated with serious health issues, including preterm births,
infertility, pelvic inflammatory disease, increased susceptibility
to sexual transmitted infections (including HIV infection) and
other chronic health problems.1,2
DARE-BV1 features a novel thermosetting hydrogel delivery
technology that is easy to apply, highly viscous and may have
better bio-adhesion when compared to commonly prescribed creams and
gels used to treat BV. It is believed that these unique formulation
characteristics result in better antibiotic delivery to the vaginal
infection leading to higher clinical cure rates and better clinical
outcomes. Daré intends to start a single Phase 3 registrational
trial of DARE-BV1 later this year.
The poster will be presented by Dr. Friend.
Presentation details are below. The poster will also be
made available on the Events and Presentations page of Daré’s
investor relations website (http://ir.darebioscience.com).
Title: Proof of Concept Study to Evaluate the
Efficacy of a Novel Thermosetting Bioadhesive 2% Clindamycin
Phosphate Vaginal Gel in the Treatment Bacterial Vaginosis
Dates & Times: Thursday, August 8, 2019,
4:00 PM – 5:00 PM (Mountain Daylight Time)Friday, August 9, 1:30 PM
– 2:30 PM (MDT)
1. Center for Disease Control and Prevention (CDC).
www.cdc.gov/std/bv/stats.htm2. Onderdonk, A. et al. “The Human
Microbiome during Bacterial Vaginosis,” Clinical Microbiology
Reviews, April 2016 Volume 29 Number 2
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 non-hormonal,
monthly contraceptive intravaginal ring; 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 bioidentical 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
uses these channels to communicate with its investors and the
public about the company and other company-related matters. The
information Daré posts on its investor relations website 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:
www.darebioscience.com.
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, statements relating to the
potential of DARE-BV1 to treat bacterial vaginosis, the timing of
Daré’s Phase 3 clinical study of DARE-BV1 and the potential for
regulatory approval of DARE-BV1 based on a single, successful Phase
3 clinical study. 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;
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 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; 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:Lee RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake@canalecomm.com619.849.5383
Source: Daré Bioscience
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Apr 2024 to May 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From May 2023 to May 2024