Clinical Data Evaluating Gencaro for the Treatment of Atrial Fibrillation in Heart Failure Patients Featured in Three Present...
May 07 2020 - 7:30AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today announced
that clinical data evaluating Gencaro™ (bucindolol
hydrochloride) as a potential treatment for atrial fibrillation
(AF) in patients with heart failure (HF) was presented at the 2020
Heart Rhythm Scientific Sessions, the annual scientific conference
of the Heart Rhythm Society (HRS). While the in-person meeting was
cancelled due to the continued global escalation of COVID-19, HRS
has provided author presentations virtually through its online
learning platform Heart Rhythm 365 and all abstracts will be
published in a supplement to the May edition of the Heart Rhythm
Journal.
The data come from a Phase 2 clinical trial,
GENETIC-AF, that enrolled 267 HF patients with a current or recent
history of paroxysmal or persistent AF and the ADRB1 Arg389Arg
genotype. Patients were randomized to bucindolol or the active
comparator, metoprolol succinate, and were followed for
approximately 24 weeks.
“Pharmacogenomic Guided Beta-Blocker Therapy
with Bucindolol Reduces Atrial Fibrillation Burden Compared to
Metoprolol Succinate: The GENETIC-AF Trial,” authored by Jonathon
P. Piccini et al, presented data from the device substudy of the
GENETIC-AF trial. A total of 69 HF patients underwent continuous
heart rhythm monitoring via implanted cardiac devices to evaluate
the total time spent in AF during 24 weeks of follow-up, also known
as cumulative AF burden. The paper’s authors concluded that:
- Bucindolol decreased cumulative AF burden by 26% (p < 0.001)
compared to active control.
- Treatment effect estimates for cumulative AF burden were
consistent with time to first AF event analyses.
- Cumulative AF burden evaluates more information than time to
first event methods, providing greater power to detect clinically
meaningful differences between groups with limited sample
size.
“Impact of Pharmacogenetic-guided Bucindolol
versus Metoprolol Succinate on the Overall Burden of Clinical
Events in Patients with AF and Heart Failure: The GENETIC-AF
Trial,” authored by Jeff S. Healey et al, presented data on the
frequency of AF rhythm interventions (i.e., electrical
cardioversions, ablations, and Class 3 antiarrhythmic drug use)
and cardiovascular (CV) adverse events in the GENETIC-AF
trial. The paper’s authors found that:
- Bucindolol decreased a composite endpoint of AF interventions
and CV adverse events by 30% (p = 0.008) compared to active
control.
- Bucindolol decreased AF interventions by 33% (p = 0.009)
compared to active control.
- Significant and numerically greater results were observed (46%
and 51%, respectively) in a subgroup previously identified by
precision therapeutic phenotyping (PTP cohort).
- Similar significant results were observed (55% and 58%,
respectively) for a subgroup of the PTP cohort with baseline LVEF
values of 40% to 55%.
“Bucindolol is Associated with a Lower Incidence
of Dose Limiting Bradycardia in Heart Failure Patients with Atrial
Fibrillation: The GENETIC-AF Trial,” authored by William T. Abraham
et al, reviewed drug dosing and safety data for the GENETIC-AF
trial. The paper’s authors found that:
- Bucindolol was associated with a 55% (p < 0.001) lower
incidence of bradycardia compared to active control.
- Bradycardia was associated with a 4-fold increase in study drug
dose reductions.
- Differences in study drug dosing were primarily observed in
patients with heart rates less than 60 beats per minute, which was
much more common in the metoprolol group (p < 0.0001).
- Fewer bradycardia adverse events in the bucindolol vs.
metoprolol groups (5 vs. 20 events, p = 0.003).
- Bradycardia may limit dosing of conventional beta-blockers in
HF patients with AF, which would be expected to compromise
effectiveness for reducing HF clinical events.
The individual presentations can be found on the
Scientific Publications page of the ARCA website and at HRS’ Heart
Rhythm 365.
Michael Bristow, MD, PhD and CEO of ARCA
commented: "Evaluated by the most sensitive and comprehensive
measure of atrial fibrillation, continuous heart rhythm monitoring
by an implanted device, these data indicate a clear efficacy signal
for bucindolol compared to metoprolol succinate. Even more striking
is the beneficial effect of bucindolol on downstream AF-related
events occurring after an initial AF episode, with fewer clinical
interventions to manage heart rhythm seen in the bucindolol group.
Finally, the lower incidence of dose-limiting bradycardia with
bucindolol provides a clue as to why conventional beta-blockers
have not demonstrated efficacy for reducing heart failure events in
patients with atrial fibrillation, while bucindolol has."
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA’s lead product candidate,
Gencaro™ (bucindolol hydrochloride), is an investigational,
pharmacologically unique beta-blocker and mild vasodilator being
developed for the potential treatment of atrial fibrillation in
heart failure patients. 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 U.S. FDA has granted the
Gencaro development program Fast Track designation and a Special
Protocol Assessment (SPA) agreement for a single Phase 3 clinical
trial. ARCA is also developing AB171, a thiol-substituted
isosorbide mononitrate, as a potential genetically targeted
treatment for heart failure and peripheral arterial disease. For
more information, please visit www.arcabio.com or follow the
Company on LinkedIn.
Safe Harbor StatementThis 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 future development plans for Gencaro, 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, the significance of the new
additional data from GENETIC-AF contained in these presentations
and whether these data may be confirmed in future clinical trials,
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’s ability to raise sufficient capital on
acceptable terms, or at all, to continue development of Gencaro or
to otherwise continue operations in the future; that 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, 2019, and
subsequent filings. ARCA disclaims any intent or obligation to
update these forward-looking statements.
A photo accompanying this announcement is available
at: https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
Investor & Media
Contact:Derek Cole720.940.2163derek.cole@arcabio.com
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