GENETIC-AF Phase 2B Clinical Trial Atrial Fibrillation Burden (AFB) Results Presented at American Heart Association 2018 Scie...
November 12 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 were presented
November 11, 2018 in a poster session at the American Heart
Association 2018 Scientific Sessions in Chicago. Jonathan Piccini,
MD, MHS, FACC, FAHA, Associate Professor of Medicine and Director
of the Duke Center for Atrial Fibrillation, Duke University Medical
Center, presented the data.
GENETIC-AF was a Phase 2B, double-blind,
superiority clinical trial evaluating GencaroTM (bucindolol
hydrochloride) as a genetically-targeted treatment for atrial
fibrillation (AF) in patients with heart failure and reduced left
ventricular ejection fraction (HFrEF). Safety data indicated that
Gencaro was generally safe and well-tolerated in the AF/HFrEF
population investigated with a safety profile similar to the active
comparator metoprolol succinate (TOPROL-XL).
The primary endpoint results for the trial were
determined by intermittent, clinic-based heart rhythm monitoring.
However, a subset of patients (N=69) also underwent continuous
heart rhythm monitoring with Medtronic implanted devices to
determine AF recurrence based on AFB, a method that can identify AF
with more certainty than intermittent clinic-based monitoring. A
prespecified time-to-first event analysis was conducted using a
total AFB of at least 6 hours per day to define an event of AF
recurrence, as this criterion has been previously shown to be
associated with an increased rate of HF hospitalizations.
In this substudy, Gencaro demonstrated similar
trends for benefit compared to TOPROL-XL for the endpoint of time
to AF recurrence when measured by continuous monitoring with
implanted devices and by intermittent ECG-based monitoring (69
patients; hazard ratio = 0.73; 95% confidence interval: 0.34, 1.58)
for both methods). Event rates were slightly higher for
device-based monitoring and the device-based endpoint occurred a
median of 6.5 days prior to ECG-based detection (p <0.0001).
Analyses were also presented for a cohort that exclude patients
with long-standing (i.e., ≥12 years) and heavily pretreated HF
and/or AF. In these analyses, a trend for benefit in favor of
Gencaro over TOPROL-XL was observed in the overall population (230
patients; hazard ratio = 0.68; 95% confidence interval: 0.45, 1.02)
and in the AFB substudy population using device-based detection (60
patients; hazard ratio = 0.61; 95% confidence interval: 0.25, 1.44)
and ECG-based detection (60 patients; hazard ratio = 0.60; 95%
confidence interval: 0.25, 1.43).
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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