ARCA biopharma Announces 75th Patient Enrolled in GENETIC-AF Phase 2B/3 Clinical Trial
18 April 2016 - 11:00PM
Business Wire
GENETIC-AF Evaluating Gencaro as Potentially
First Genetically-Targeted Treatment for Atrial
Fibrillation
Outcome of Interim Efficacy Analysis of Data
from Approximately 150 Patients Anticipated in the Second Quarter
of 2017
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today announced that the 75th patient has been enrolled
in GENETIC-AF, a Phase 2B/3 clinical trial evaluating Gencaro as a
potential treatment for atrial fibrillation. Seventy-five patients
enrolled is the midpoint of the minimum number of patients to be
evaluated in the Phase 2B portion of the trial.
Based on the current enrollment rate, the Company expects to
enroll at least 150 patients in the trial by the end of 2016. The
Company expects the outcome of a pre-specified GENETIC-AF Data
Safety Monitoring Board (DSMB) interim efficacy, safety and
futility analysis of data from approximately 150 patients in the
second quarter of 2017. Based on the outcome of the interim
analysis, the DSMB will recommend whether or not the GENETIC-AF
trial should proceed to the Phase 3 portion of the trial.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized,
double-blind, adaptive design clinical trial comparing the safety
and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the
treatment of atrial fibrillation (AF) in approximately 620
patients. Eligible patients will have heart failure with reduced
left ventricular ejection fraction (HFREF), have 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 have 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/atrial flutter (AFL) or all-cause mortality. The combined Phase
2B/Phase 3 trial is designed for 90 percent power at a p-value of
less than 0.01 significance level to detect a 25 percent reduction
in the primary endpoint for patients in the Gencaro arm compared to
patients in the Toprol-XL arm. The trial is currently enrolling
patients in the United States and Canada.
The DSMB will conduct a pre-specified interim analysis of study
endpoints for efficacy, safety and futility to recommend whether or
not the trial should proceed to Phase 3. The DSMB will make its
recommendation based on a predictive probability analysis of
certain trial data after at least 150 patients have evaluable
endpoint data. An enrolled patient has evaluable endpoint data
either when they experience their first endpoint event, or after
they complete the 24-week follow up period. The DSMB interim
analysis will focus on analyses of the AF/AFL endpoints in the
trial using both clinical-based intermittent monitoring and
device-based continuous monitoring techniques. Should the DSMB
interim analysis indicate that the data are consistent with
pre-trial statistical assumptions and the potential for achieving
statistical significance for the Phase 3 endpoint, the DSMB may
recommend that the study proceed to Phase 3. The DSMB may also halt
the study for futility.
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 2016
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, Gencaro™ (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 and related recommendations of the
DSMB, 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, 2015,
and subsequent filings. The Company disclaims any intent or
obligation to update these forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160418005435/en/
Investor & Media Contact:ARCA biopharma, Inc.Derek
Cole, 720-940-2163derek.cole@arcabiopharma.com
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Apr 2024 to May 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From May 2023 to May 2024