ARCA biopharma Announces Completion of Enrollment for GENETIC-AF Phase 2B Clinical Trial
August 16 2017 - 8:30AM
GENETIC-AF Evaluating Gencaro as
Potentially First
Genetically-Targeted Treatment for Atrial
Fibrillation
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced the completion of enrollment for GENETIC-AF, a Phase 2B,
double-blind, superiority clinical trial evaluating GencaroTM
(bucindolol hydrochloride) as a potential genetically-targeted
treatment for atrial fibrillation (AF). ARCA expects to
report top-line Phase 2B data late in the first quarter of 2018.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
Two-hundred sixty-seven patients were randomized
into the trial, slightly exceeding the target enrollment of 250
patients. The trial enrolled patients from the United States,
Canada and Europe.
“We believe reaching our target enrollment in
GENETIC-AF represents a key clinical milestone for ARCA and we look
forward to reporting top-line data for the trial, which we estimate
should include approximately 50% more events than were available at
the recently conducted interim analysis,” commented Dr. Michael
Bristow, ARCA’s President and CEO. “I would like to thank our
clinical investigators as well as the patients and their families
for their participation. We will continue working diligently
to advance Gencaro’s pharmacogenetic clinical and regulatory
development."
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B, multi-center,
randomized, double-blind, superiority clinical trial comparing the
safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate)
for the treatment and prevention of recurrent atrial fibrillation
or flutter (AF/AFL) in heart failure patients with reduced left
ventricular ejection fraction (HFrEF). Eligible patients have
HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less)
or persistent AF (episodes lasting more than 7 days and less than 1
year) in the past 6 months, and the beta-1 389 arginine homozygous
genotype that ARCA believes responds most favorably to
Gencaro. The GENETIC-AF Data and Safety Monitoring Board
(DSMB) conducted a pre-specified interim analysis of all patients
randomized as of June 19, 2017. Based on its efficacy and
safety review, the DSMB recommended completion of the Phase 2B
trial with no changes to the trial design and indicated that there
were no safety concerns.
About ARCA biopharma
ARCA biopharma is dedicated to developing
genetically-targeted therapies for cardiovascular diseases through
a precision medicine approach to drug development. ARCA’s
lead product candidate, GencaroTM (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of patients
with atrial fibrillation and HFrEF, currently in a Phase 2B
clinical trial. ARCA has identified common genetic variations
that it believes predict individual patient response to Gencaro,
giving it the potential to be the first genetically-targeted atrial
fibrillation prevention treatment. ARCA has a collaboration
with Medtronic, Inc. for support of the GENETIC-AF trial. The
Gencaro development program has been granted Fast Track designation
by the FDA. For more information, please visit
www.arcabio.com.
Safe Harbor Statement
This press release contains "forward-looking
statements" for purposes of the safe harbor provided by the Private
Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding, the
potential timeline for GENETIC-AF trial activities, potential
timing for the announcement of topline data for the Phase 2B
GENETIC-AF trial, the sufficiency of ARCA’s capital to support its
operations, the expected features and characteristics of Gencaro,
including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat AF, future treatment options for patients with AF, and the
potential for Gencaro to be the first genetically-targeted AF
prevention treatment. Such statements are based on
management's current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, the
risks and uncertainties associated with: ARCA’s financial resources
and whether they will be sufficient to meet its business objectives
and operational requirements; results of earlier clinical trials
may not be confirmed in future trials; the protection and market
exclusivity provided by ARCA’s intellectual property; risks related
to the drug discovery and the regulatory approval process; and, the
impact of competitive products and technological changes.
These and other factors are identified and described in more detail
in ARCA’s filings with the Securities and Exchange Commission,
including without limitation ARCA’s annual report on Form 10-K for
the year ended December 31, 2016, and subsequent filings.
ARCA disclaims any intent or obligation to update these
forward-looking statements.
Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabio.com
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