ARCA biopharma Announces Phase 2B GENETIC-AF Clinical Trial Results Selected for Late Breaking Oral Presentation at European ...
May 10 2018 - 8:30AM
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced that data from the Phase 2B GENETIC-AF clinical trial has
been selected for a “Late Breaking Clinical Trials” oral
presentation at the European Society of Cardiology Heart Failure
2018 World Congress being held May 26-29, 2018 in Vienna,
Austria. William T. Abraham, M.D., Professor of Medicine,
Physiology and Cell Biology and Director, Division of
Cardiovascular Medicine at the Ohio State University will present
the data.
Presentation Number and Title:
#674, “Phase II Trial of Pharmacogenetic Guided Beta-Blocker
Therapy with Bucindolol vs. Metoprolol for the Prevention of Atrial
Fibrillation/Flutter in Heart Failure: GENETIC-AF”
Session: Late Breaking Trial II
– Chronic Heart Failure
Session Date and Time: Sunday,
May 27, 2018; 8:30 – 10:00 a.m.
GENETIC-AF Presentation Time:
9:00 a.m.
About GENETIC-AF
A Genotype-Directed Comparative
Effectiveness Trial of Bucindolol
and Toprol-XL for Prevention of Symptomatic Atrial
Fibrillation/Atrial Flutter in Patients with Heart
Failure
GENETIC-AF was a Phase 2B multi-center,
randomized, double-blind, clinical superiority trial comparing the
safety and efficacy of Gencaro™ against an active comparator, the
beta-blocker 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 had 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
we believe responds most favorably to Gencaro™. A subset of
patients in the trial also underwent continuous heart rhythm
monitoring to assess AF burden, which is defined as the amount of
time per day that a patient experiences AF. Topline results of
GENETIC-AF were reported on February 26, 2018.
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 (AF) and chronic heart failure with
reduced left ventricular ejection fraction (HFrEF) which recently
completed 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 AF 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 FDA. ARCA also plans to develop AB171, a
thiol-substituted isosorbide mononitrate, as a potential
genetically-targeted treatment for peripheral arterial disease
(PAD) and for heart failure (HF). 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 ability of ARCA’s
financial resources to support its operations through the end of
2018, potential future development plans for Gencaro, the expected
features and characteristics of Gencaro or AB171, including the
potential for genetic variations to predict individual patient
response to Gencaro, Gencaro’s potential to treat AF, AB171’s
potential to treat HF, 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; ARCA may not be able to raise
sufficient capital on acceptable terms, or at all, to continue
development of Gencaro or to otherwise continue operations in the
future; 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, 2017, 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
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