ARCA Biopharma announces phase 2B GENETIC-AF atrial fibrillation burden (AFB) results selected for presentation at american h...
November 05 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 Atrial Fibrillation Burden (AFB)
substudy of the Phase 2B GENETIC-AF clinical trial have been
selected for a poster presentation at the American Heart
Association 2018 Scientific Sessions being held November 10-12,
2018 in Chicago. Jonathan Piccini, MD, MHS, FACC, FAHA, FHRS,
Associate Professor of Medicine and Director of the Duke Center for
Atrial Fibrillation, Duke University Medical Center, will present
the data.
Presentation Number and Title:
Board Number 4080, “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 Af Burden Substudy”
Session: Abstract Poster
Session – Treatment of Arrhythmias: Pharmacologic I
Session Date and Time: Sunday,
November 11, 2018; 10:30 – 11:45 a.m. CT
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 (LVEF). Eligible patients had LVEF < 50%, 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™. A subset
of patients in the trial also underwent continuous heart rhythm
monitoring to assess AF burden, which was defined as a patient
experiencing at least six hours of AF in a day. 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 heart
failure (HF) patients at risk for atrial fibrillation (AF). 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.
The Gencaro development program has been granted Fast Track
designation by FDA. ARCA is also developing 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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