ARCA biopharma Announces 200th Patient Randomized into the GENETIC-AF Seamless Design Phase 2B/3 Clinical Trial
April 26 2017 - 8:30AM
Business Wire
Outcome of Phase 2B Interim Efficacy
Analysis Anticipated in September 2017
80% of Phase 2B Planned Patient Enrollment
Completed
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 200th patient has been randomized into the
GENETIC-AF clinical trial evaluating Gencaro™ (bucindolol
hydrochloride) as potentially the first genetically-targeted
treatment for atrial fibrillation (AF).
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View the full release here:
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Dr. Michael Bristow, President and CEO,
ARCA biopharma, Inc. (Photo: Business Wire)
“The enrollment strategies we’ve implemented have increased the
rate of patient enrollment. We’d like to thank the investigators
and enrolled patients, whose support and enthusiasm suggests a high
unmet medical need for this patient population and potentially a
substantial market opportunity if Gencaro is approved,” commented
Dr. Michael Bristow, ARCA’s President and CEO. “With the Phase 2B
portion of the trial nearing completion, we are focused on the
upcoming interim efficacy analysis that will determine the next
steps of this adaptive, seamless design trial. We expect the
outcome of this interim efficacy analysis in September 2017.”
GENETIC-AF Clinical Trial
GENETIC-AF is an adaptive, seamless design Phase 2B/3,
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 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 ARCA
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.
Phase 2B Interim Efficacy Analysis
The GENETIC-AF Data Safety Monitoring Board (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 to evaluate the evidence for safety and superior
efficacy of Gencaro versus the active comparator, metoprolol
succinate (TOPROL-XL).
The prospectively defined features of this analysis include an
estimate of Gencaro effectiveness relative to TOPROL-XL and 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 (a measure of an effect of an intervention on
an outcome of interest over time) 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.
ARCA, in collaboration with the trial Steering Committee, will
determine the most appropriate 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. ARCA expects the outcome of this interim
efficacy analysis in September 2017.
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,
Gencaro™ (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. 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 ARCA’s capital to support its operations,
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.
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Investor & Media Contact:ARCA biopharma,
Inc.Derek Cole, 720-940-2163derek.cole@arcabio.com
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