Daré Bioscience, Inc. (NASDAQ: DARE), a
leader in women’s health innovation, today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation for DARE-BV1 for the treatment of bacterial vaginosis
(BV) in women. DARE-BV1 was previously granted Qualified Infectious
Disease Product (QIDP) designation for the treatment of BV in
August 2019. DARE-BV1 is a novel thermosetting bioadhesive
hydrogel containing clindamycin phosphate 2% being developed for
one-time vaginal administration for the treatment of BV.
“BV is estimated to affect more than 20 million women in the
United States and has been associated with pre-term birth and
infertility. With clinical cure rates of current FDA-approved
products in the range of 37-68% and a high rate of recurrence, this
condition requires more innovative, effective medicines,” said
Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
“Our Fast Track Designation for DARE-BV1 underscores that BV is a
serious infection for which current treatment options are
inadequate and validates DARE-BV1’s potential to address this unmet
medical need.”
BV is the most common cause of vaginitis worldwide.1 While there
are a number of FDA-approved treatment options for women diagnosed
with BV, most have relatively low clinical cure rates (37-68%),
which may be one of the key drivers of recurrence rates. It is
estimated that as many as 50% of women treated for BV will
experience a recurrence within twelve months of their treatment.2
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.
Daré plans to initiate a Phase 3 clinical study of DARE-BV1 in
approximately 220 women with an anticipated topline data readout by
the end of 2020 to support the New Drug Application (NDA)
submission. Based on discussions with the FDA, the Phase 3
study will include a placebo control and assess the primary
endpoint of clinical cure of BV (defined as resolution of specified
clinical signs and symptoms from baseline visit) at the
test-of-cure visit to occur 21 to 30 days after enrollment in the
study. If this single Phase 3 study and the nonclinical studies to
be conducted in parallel with the Phase 3 study are successful,
Daré intends to file the NDA following the completion of the Phase
3 study.
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 frequent
interactions with the FDA to discuss the drug’s development plan
and ensure collection of appropriate data needed. 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.
BV has been associated with serious health issues, including
preterm births, pelvic inflammatory disease, increased
susceptibility to sexual transmitted infections (including HIV
infection) and other chronic health problems.3 It is estimated
that BV is present in at least 15% of the sexually active
population making it more common than urinary tract infections and
many times more common than the Trichomonas
vaginalis infection and vulvovaginal candidiasis.4
- Clinical Infectious Diseases 2007;
44:213–9; https://doi.org/10.1086/509577
- The Journal of Infectious Diseases 2006;
193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274
- Centers for Disease Control and
Prevention, www.cdc.gov/std/bv/stats.htm; Onderdonk, A. et al.
“The Human Microbiome during Bacterial Vaginosis,” Clinical
Microbiology Reviews, April 2016 Volume 29 Number 2
- Clinical Infectious Diseases 2007;
44:220–1; https://doi.org/10.1086/509584
About Daré BioscienceDaré 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 StatementsDaré 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 BV, the potential for DARE-BV1 to
demonstrate a higher clinical cure rate than current FDA-approved
BV treatments, the timing of the Phase 3 clinical study of DARE-BV1
and availability of topline results of the study, the potential for
regulatory approval of DARE-BV1 based on a single, successful Phase
3 clinical study and the anticipated benefits of Fast Track
designation for DARE-BV1. 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; 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; the risk that positive findings in early
clinical studies of a product candidate may not be predictive of
success in subsequent clinical studies of that candidate; the risk
that a product candidate may fail to demonstrate equivalent or
superior efficacy and/or safety in a pivotal clinical study
compared to results from a pre-pivotal study or studies; 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
Lee Roth +1 212-213-0006 Burns McClellan
Email: lroth@burnsmc.com
OR
Media Jake Robison +1 619-849-5383 Canale Communications
Email: jake@canalecomm.com
Source: Daré Bioscience, Inc.
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