ARCA biopharma Announces Completion of GENETIC-AF Phase 2B Clinical Trial
January 08 2018 - 8:30AM
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GENETIC-AF Evaluating Gencaro as Potentially First
Genetically-Targeted Treatment for Atrial
Fibrillation--------------------------------------------------------------------------------------------------
ARCA Estimates Reporting Top-line Phase 2B Data in March
2018
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 patient follow-up 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). All
patients completed their last study visits and were transitioned
off study drug by the end of December 2017. ARCA expects to report
top-line Phase 2B data in March 2018.
“Completion of patient treatment 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
previously 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 atrial 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 in August 2017.
Based on its efficacy and safety review, the DSMB recommended
completion of the Phase 2B trial and indicated there were no safety
concerns. The other protocol specified options for the interim
analysis were accelerated development that would have transitioned
the trial seamlessly to a larger Phase 3 trial of approximately 620
patients, or immediately stopping for futility.
The Phase 2B trial enrolled 267 patients from
the United States, Canada and Europe. All patients have completed
their last study visits and transitioned off study drug. ARCA is
currently performing final monitoring visits and anticipates having
evaluable data for approximately 250 patients in the final Phase 2B
analysis. 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.
As the trial was statistically powered for the
larger Phase 3 population, the final Phase 2B analysis will follow
the same Bayesian methodology that was employed in the DSMB interim
analysis, i.e., modeling the predictive probability of success
(PPOS) of a future 620-patient Phase 3 study based on the time to
first event of AF/AFL or all-cause mortality endpoint.
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
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 Cole720.940.2163derek.cole@arcabio.com
A photo accompanying this announcement is
available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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