Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced positive topline results from the
DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled
clinical trial evaluating DARE-BV1 in 307 women diagnosed with
bacterial vaginosis, a serious condition estimated to affect
approximately 21 million women in the United States. DARE-BV1 is an
investigational thermosetting bioadhesive hydrogel containing
clindamycin phosphate 2% designed as a convenient, one-time
vaginally-administered treatment for bacterial vaginosis. The trial
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.
“Based on these topline results, DARE-BV1 delivered clinical
cure rate values greater than those of currently marketed
FDA-approved products for the treatment of bacterial vaginosis.
This successful Phase 3 clinical trial marks another important
achievement for Daré. We began 2020 with the announcement of a
commercial partnership for Ovaprene® with Bayer, marketer of one of
the most successful contraceptive products in women’s health, and
we’re concluding the year with another exciting milestone, the
successful completion of our Phase 3 clinical trial of DARE-BV1 to
support an NDA for the treatment of bacterial vaginosis,” said
Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We
believe there is a large unmet need for a more efficacious and
convenient, single-dose vaginally-administered product to treat
bacterial vaginosis, and we believe DARE-BV1 could become a new
front-line treatment option. DARE-BV1 received Fast Track
designation from the FDA earlier this year and, based on the
topline results of this trial, we plan to file our NDA in the first
half of 2021.”
Topline Results of the Phase 3
Randomized Clinical TrialDARE-BVFREE randomized 307 women
at 32 centers across the United States in a 2:1 ratio to receive a
single vaginal dose of DARE-BV1 (N=204) or a single vaginal dose of
placebo gel (N=103) to be applied intravaginally within one day of
randomization.
The primary endpoint for the study was clinical cure of
bacterial vaginosis determined at the final study visit which
occurred 21 to 30 days after study drug administration, also
referred to as the test-of-cure (TOC) visit, in the modified
intent-to-treat (mITT) study population (N=180). In accordance with
U.S. Food and Drug Administration (FDA) guidance, the mITT
population excludes subjects from the intent-to-treat (ITT)
population (N=307) who subsequently demonstrated a positive test
result for other concomitant vaginal or cervical infections at
baseline.
A single vaginal dose of DARE-BV1 proved statistically superior
to placebo at p-value < 0.001 at the TOC visit that occurred 21
to 30 days after study drug administration (primary efficacy
endpoint) and also at the assessment visit that occurred 7 to 14
days after study drug administration. DARE-BV1 also demonstrated
statistically significant efficacy in all four additional
pre-specified secondary efficacy assessments. The clinical cure
endpoint results are shown in the following table:
Summary of Clinical Cure Results (mITT
Population), p-value < 0.001:
|
DARE-BV1(N = 121) |
Placebo(N = 59) |
Clinical Cure at Day 7-14 visit |
76.0% |
23.7% |
Clinical Cure at Day 21-30 visit (primary endpoint) |
70.2% |
35.6% |
The clinical cure rate at the Day 21-30 visit for the ITT
population was similar to that for the mITT population (70.1% for
the DARE-BV1 group (N=204) and 36.9% for the placebo group (N=103),
p-value < 0.001), demonstrating effectiveness of DARE-BV1 in
treating bacterial vaginosis even when other concomitant vaginal or
cervical infections were present.
The DARE-BVFREE study’s two treatment arms were well balanced in
terms of age, race, ethnicity, bacterial vaginosis history, and
body mass index (BMI). The ITT population comprised primarily
patients aged 15 to 51 years, with a mean age of 34.8 (standard
deviation 8.84) and median age of 35. Over 53% of the ITT
population qualified as obese (BMI ≥30.0), with a mean BMI of 31.50
(standard deviation 8.499). In the ITT population, 56.0% of women
identified as Black or African American, 41% identified as white
and 25.5% identified as of Hispanic or Latino origin (compared to
74.5% as not of Hispanic or Latino origin). In addition, more than
75% of the women in the ITT population reported one or more
episodes of bacterial vaginosis diagnosed in the 12 months before
they were randomized into the study (76.9% in the DARE-BV1 group
and 73.8% in the placebo group).
DARE-BV1 was well-tolerated in the study. There were no early
discontinuations due to adverse events (AEs), and the only serious
AE occurred in a woman in the placebo group. In the DARE-BV1 group,
15.3% of patients reported AEs that were considered to be possibly,
probably or definitely related to study treatment compared to 9.7%
of patients in the placebo group.
Only two AEs were reported by more than 2% of patients in the
DARE-BV1 arm and at a rate higher than in patients in the placebo
arm – vulvovaginal candidiasis, commonly called a vaginal yeast
infection (17.2% in the DARE-BV1 group and 3.9% in the placebo
group), and vulvovaginal pruritus, commonly referred to as vaginal
itching (4.4% in the DARE-BV1 group and 1.9% in the placebo group).
Over half of the vaginal yeast infections reported in the DARE-BV1
group and exactly half of those reported in the placebo group
occurred in patients who exhibited a positive yeast culture prior
to dosing.
"We believe these data demonstrate that DARE-BV1 is
significantly effective in a representative patient population,
including a large proportion of patients who have been previously
treated for this infection. Today, about half of the patients
treated for bacterial vaginosis experience recurrence of the
infection within 12 months of their treatment, and currently
marketed FDA-approved products for the treatment of bacterial
vaginosis have clinical cure rates in the mid-30% to the high-60%
range,” said David Friend, PhD, Chief Scientific Officer of Daré
Bioscience. “If approved, we believe DARE-BV1 will be an important
new and convenient one-time vaginally-administered treatment option
with the potential to improve clinical outcomes and overall quality
of life for women suffering with bacterial vaginosis.”
Based on the topline results from the study, Daré expects to
have a pre-NDA meeting with the FDA in early 2021 and to submit an
NDA during the first half of 2021. DARE-BV1 received both Fast
Track and Qualified Infectious Disease Product (QIDP) designations
from the FDA for the treatment of bacterial vaginosis. Given these
designations, the NDA could be eligible for priority review, which,
if granted, could allow for a 2021 PDUFA date, and, assuming
approval, an early 2022 commercial launch in the U.S.
About the Phase 3
Study
DARE-BVFREE was a randomized, multicenter, double-blind,
placebo-controlled study of a single administration of DARE-BV1
(clindamycin phosphate vaginal gel, 2%) compared to a single
administration of placebo vaginal gel (HEC Universal Placebo Gel)
for the treatment of bacterial vaginosis. Patients were evaluated
during three clinic visits: Day 1 (screening and randomization
visit), Day 7-14 (assessment visit), and Day 21-30 (TOC visit).
Clinical cure was defined as resolution of the specific clinical
signs that comprise the Amsel criteria; specifically, resolution of
abnormal vaginal discharge associated with bacterial vaginosis,
clue cells less than 20% of total epithelial cells on microscopy,
and a negative 10% KOH “whiff” test. The total study duration was
approximately one month for each individual patient.
About Bacterial Vaginosis
Bacterial vaginosis is the most common cause of vaginitis
worldwide and is estimated to affect approximately 21 million women
in the United States.1,2 Prevalence of bacterial vaginosis among
non-white women in the U.S. is higher than among white women
(African American 51%, Mexican American 32%, white 23%).2 While
there are several therapeutic options for women in the U.S.
diagnosed with bacterial vaginosis, currently approved options have
relatively insufficient clinical cure rates, require sequential
daily administrations or can be otherwise inconvenient for women to
use. It is estimated that as many as 50% of women treated for
bacterial vaginosis will experience a recurrence within 12 months
of their treatment.3
- Clinical Infectious Diseases 2007;
44:213–9; https://doi.org/10.1086/509577
- Centers for Disease Control and
Prevention Bacterial Vaginosis (BV) Statistics;
https://www.cdc.gov/std/bv/stats.htm. Accessed December 5,
2020.
- The Journal of Infectious Diseases
2006; 193:1478–86;
https://www.ncbi.nlm.nih.gov/pubmed/16652274
About DARE-BV1
DARE-BV1 is an investigational thermosetting bioadhesive
hydrogel containing clindamycin phosphate 2% being evaluated as a
one-time, vaginally-administered treatment for bacterial
vaginosis.
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 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 Daré’s plans and strategies for regulatory
approval and commercialization of DARE-BV1, including expected
timing of Daré’s engagement with the FDA regarding an NDA for
DARE-BV1, submission of an NDA for DARE-BV1, FDA review and
approval of the NDA, and commercial launch of DARE-BV1 in the U.S.
if approved; DARE-BV1’s potential importance to and utilization by
women with bacterial vaginosis, including its potential ability to
improve clinical outcomes and overall quality of life compared to
currently available therapeutic options for bacterial vaginosis if
approved; 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 topline results from a clinical trial, including the
DARE-BVFREE study, are based on Daré’s preliminary analysis of key
efficacy and safety data and, following a comprehensive review of
study data, such results may change and topline results may not
accurately reflect the complete results from the clinical trial;
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 study data;
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 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; the risks that the license agreement with
Bayer may not become effective and, if it becomes effective, that
future payments to Daré under the agreement may be significantly
less than anticipated or potential amounts; 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; 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.
Investors on behalf of Daré Bioscience, Inc.:Lee RothBurns
McClellanEmail: lroth@burnsmc.com+1 212-213-0006
Source: Daré Bioscience, Inc.
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