Enrollment for Phase 2B Interim Analysis of Efficacy Data Expected by
Year-End 2016
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular diseases,
today provided an update on GENETIC-AF, the Company’s Phase 2B/3
clinical trial evaluating GencaroTM (bucindolol
hydrochloride) as a potential genetically-targeted treatment for the
prevention of atrial fibrillation.
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Dr. Michael R. Bristow, President and CEO, ARCA biopharma, Inc. (Photo: Business Wire)
Fifty (50) patients have been enrolled in the GENETIC-AF trial. By the
end of 2016, the Company anticipates enrollment of a sufficient number
of patients for the Data Safety Monitoring Board (DSMB) interim analysis
of Phase 2B efficacy data. Allowing for patients to complete their
24-week treatment period, the outcome of the DSMB interim analysis is
expected in the first half of 2017.
“We are pleased with the clinical investigator support for the
GENETIC-AF trial,” commented Dr. Michael Bristow, ARCA’s President and
CEO. “Under the revised trial protocol, which broadened the target
patient population, patient enrollment in the trial has increased
steadily over the past several months. We expect the DSMB interim
analysis of Phase 2B efficacy data, and the potential DSMB
recommendation to convert the trial to a pivotal Phase 3 trial, to occur
in the first half of 2017.”
There are currently 60 clinical trial sites in the United States and
Canada, with 5 additional sites in start-up.
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GENETIC-AF Trial Phase 2B Projected Timeline
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• Revised protocol distributed to participating clinical trial
sites
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March 2015
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• GENETIC-AF Trial Investigators meeting and training
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May
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• First trial sites operating under revised protocol
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May
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• Approximately 65 clinical trial sites in U.S. & Canada
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Q4
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• First 50 patients enrolled in trial
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January 2016
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- Sufficient enrollment for Phase 2B DSMB Interim Efficacy Analysis
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YE 2016
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- DSMB Interim Analysis Decision
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1H 2017
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The Company’s forecast of the time periods to achieve these milestones
is a forward-looking statement and involves risks and uncertainties, and
actual results are likely to vary as a result of a number of factors,
including the factors discussed in “Risk Factors” in the Company’s
periodic SEC filings.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind
clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL
(metoprolol succinate) for the treatment of atrial fibrillation (AF) in
patients with heart failure and left ventricular systolic dysfunction
(HFREF patients). The primary endpoint of GENETIC-AF is time to
symptomatic AF/atrial flutter (AFL). ARCA is enrolling only HFREF
patients with the genetic variant of the cardiac beta-1 adrenergic
receptor, which the Company believes responds most favorably to Gencaro,
the 389 arginine homozygous genotype (ADRB1 Arg389Arg).
GENETIC-AF has an adaptive design, under which the Company initiated the
trial as a Phase 2B trial. The GENETIC-AF Data Safety Monitoring Board
(DSMB) will analyze certain data from the Phase 2B portion of the trial
and recommend, based on a comparison to the pre-trial statistical
assumptions, whether the trial should proceed to Phase 3. The Company
expects GENETIC-AF will enroll a combined 620 patients over the Phase 2B
and Phase 3 portions of the trial.
Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained cardiac arrhythmia, is
considered an epidemic cardiovascular disease and a major public health
burden. The estimated number of individuals with AF globally in 2010 was
33.5 million. According to the 2015 American Heart Association report on
Heart Disease and Stroke Statistics, the estimated number of individuals
with AF in the United States in 2010 ranged from 2.7 million to
6.1 million people. Hospitalization rates for AF increased by 23% among
U.S. adults from 2000 to 2010 and hospitalizations account for the
majority of the economic cost burden associated with AF.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies
for cardiovascular diseases. The Company's lead product candidate,
GencaroTM (bucindolol hydrochloride), is an investigational,
pharmacologically unique beta-blocker and mild vasodilator being
developed for atrial fibrillation. 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. For more
information please visit www.arcabiopharma.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, potential timing for patient enrollment in the
GENETIC-AF trial, potential timeline for GENETIC-AF trial activities,
the sufficiency of the Company’s capital to support its operations, the
potential for genetic variations to predict individual patient response
to Gencaro, Gencaro’s potential to treat atrial fibrillation, future
treatment options for patients with atrial fibrillation, and the
potential for Gencaro to be the first genetically-targeted atrial
fibrillation 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: the Company's financial resources and whether they will be
sufficient to meet the Company's business objectives and operational
requirements; results of earlier clinical trials may not be confirmed in
future trials, the protection and market exclusivity provided by the
Company’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 SEC, including
without limitation the Company’s annual report on Form 10-K for the year
ended December 31, 2014, and subsequent filings. The Company
disclaims any intent or obligation to update these forward-looking
statements.
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