ARCA biopharma Announces 150th Patient Randomized into the GENETIC-AF Phase 2B/3 Clinical Trial
January 18 2017 - 8:30AM
Business Wire
Outcome of DSMB Interim Efficacy Analysis
Anticipated in the Third Quarter of 2017
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 that the 150th patient has been randomized into
GENETIC-AF, a seamless Phase 2B/3 clinical trial evaluating
GencaroTM (bucindolol hydrochloride) as a potential treatment for
atrial fibrillation (AF).
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Dr. Michael Bristow, President and CEO,
ARCA biopharma, Inc. (Photo: Business Wire)
The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct
a Phase 2B interim efficacy, safety and futility analysis of
evaluable data from at least 150 patients. The Company expects the
outcome of this interim analysis in the third quarter of 2017.
“This is an important milestone for the Gencaro atrial
fibrillation development program and a terrific accomplishment for
the team here at ARCA,” commented Dr. Michael Bristow, ARCA’s
President and CEO. “We are grateful for the continuing support of
the physicians, clinical investigators and patients participating
in the GENETIC-AF trial evaluating GencaroTM as potentially the
first genetically-targeted treatment for atrial fibrillation. The
Gencaro development program, if successful in GENETIC-AF, may also
herald a new era of pharmacogenetically developed cardiovascular
drugs.”
Phase 2B Interim Efficacy Analysis
GENETIC-AF is a seamless Phase 2B/3 adaptive design superiority
trial evaluating the effectiveness of Gencaro for the prevention of
recurrent atrial fibrillation or flutter (AF/AFL) in heart failure
patients with reduced left ventricular ejection fraction (HFrEF).
The DSMB will perform a pre-specified interim analysis of unblinded
efficacy data when at least 150 patients have evaluable data. A
randomized patient has evaluable data either when they experience
their first composite endpoint event, AF/AFL or all-cause
mortality, or after completion of the 24-week primary endpoint
follow-up period. The analysis will be conducted for detection of
evidence of safety and superior efficacy of Gencaro versus the
active comparator, metoprolol succinate (TOPROL-XL).
The prospectively defined features of this analysis include: 1)
an estimate of Gencaro effectiveness relative to TOPROL-XL; and, 2)
an assessment of safety as characterized by adverse events. The
relative benefit estimate will utilize Bayesian statistical methods
to calculate the predictive probability of the Phase 3 patient
cohort hazard ratio based on the interim Phase 2B data.
Prospectively defined ranges of predictive probabilities have been
predetermined to define three potential outcomes based on the
projection of the Phase 2B interim results:
1) transition the trial to Phase 3 based on a
likelihood of achieving a statistically significant hazard ratio in
favor of Gencaro (evidence of an effectiveness signal consistent
with pretrial assumptions) and enroll up to a total of 620 patients
(including the Phase 2B patients);
2) completion of the Phase 2B stage of the
trial including 24-week follow-up of all randomized subjects
(approximately 250 patients), based on an intermediate result that
is potentially favorable but does not support transition of the
trial to Phase 3 or;
3) immediate termination of the trial due to
futility.
The Company, in collaboration with the trial Steering Committee,
will determine the best path forward for the trial based on the
DSMB recommendation from this interim analysis. The unblinded
statistical data available to the DSMB will not be disclosed to the
Company or the public. The Company projects that the outcome of the
DSMB interim analysis and recommendation will be available in the
third quarter of 2017.
GENETIC-AF Clinical Trial
GENETIC-AF is a seamless Phase 2B/3, adaptive design,
multi-center, randomized, double-blind, superiority clinical trial
comparing the safety and efficacy of Gencaro to Toprol-XL
(metoprolol succinate) for the prevention of recurrent AF/AFL in
HFrEF patients. Eligible patients will 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
the Company believes responds most favorably to Gencaro. The
primary endpoint of the study is time to first event of symptomatic
AF/AFL or all-cause mortality. The trial is currently enrolling
patients in the United States, Canada and Europe.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted
therapies for cardiovascular diseases through a precision medicine
approach to drug development. 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.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 that the data
from 150 patients will support a recommendation that the GENETIC-AF
trial transition to Phase 3, the potential timeline for GENETIC-AF
trial activities and related recommendations of the DSMB, potential
timing for patient enrollment in the GENETIC-AF trial, 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 Securities and Exchange Commission, including
without limitation the Company’s annual report on Form 10-K for the
year ended December 31, 2015, and subsequent filings. The Company
disclaims any intent or obligation to update these forward-looking
statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20170118005527/en/
ARCA biopharma, Inc.Derek Cole,
720-940-2163derek.cole@arcabio.com
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