Gencaro Atrial Fibrillation Phase 2B Results Selected for Publication in Circulation: Arrhythmia and Electrophysiology
28 July 2021 - 10:00PM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today announced
that the paper entitled “Bucindolol [Gencaro] Decreases AF Burden”
(Jonathan Piccini, et al), which details a new analysis of the
Gencaro Phase 2b data on atrial fibrillation (AF) burden and rhythm
control interventions has been published in Circulation: Arrhythmia
and Electrophysiology, a journal of the American Heart Association.
In the Phase 2b superiority clinical trial, although the
prespecified primary endpoint was not met, compared with
metoprolol, Gencaro reduced AF burden, increased maintenance of
sinus rhythm, and reduced the need for additional rhythm control
interventions in patients with heart failure (HF) and the genotype
which responds most favorably to Gencaro.
In the trial, the prevalence of
electrocardiograms (ECGs) in normal sinus rhythm, AF interventions
for rhythm control (electrical cardioversion, catheter ablation and
Class III antiarrhythmic drugs), and biomarkers were evaluated in
the overall population entering efficacy follow-up (N=257). AF
burden was evaluated for 24 weeks in a device substudy (N=67) in
which all patients had continuous monitoring of cardiac rhythm by
implanted devices.
In 257 patients with HF, the mean age was 65.6 ±
10.0 years, 18% were female, mean left ventricular ejection
fraction (LVEF) was 36%, and 51% had persistent AF. Cumulative
24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and
36.7% (95% CI: 30.0, 43.5) for metoprolol (36% reduction, p
=0.002). Daily AF burden at the end of follow-up was 15.1% (95% CI:
3.2, 27.0) for bucindolol and 34.7% (95% CI: 17.9, 51.2) for
metoprolol (55% reduction, p < 0.001). The prevalence of ECGs in
normal sinus rhythm was 4.20 and 3.03 events per patient for the
bucindolol and metoprolol groups, respectively (39% increase, p
< 0.001); whereas the rate of AF rhythm control interventions
was 0.56 and 0.82 events per patient for the bucindolol and
metoprolol groups, respectively (32% reduction, p = 0.011).
Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p =
0.009) were observed with bucindolol compared to metoprolol.
Jonathan Piccini, MD, Associate Professor of
Medicine (Cardiology) and Director of the Cardiac Electrophysiology
Section at the Duke University School of Medicine and first author
of the paper stated, "Atrial fibrillation in heart failure patients
is a growing and challenging problem that is badly in need of
additional therapies, particularly those that substantially prevent
atrial fibrillation while also improving heart failure. Compared to
the GENETIC-AF primary endpoint of time to first AF event, the
reduction in AF burden measured by continuous device monitoring in
a subgroup, increase in sinus rhythm measured by ECG in all
patients and the reduction in AF interventions gives a much more
comprehensive evaluation of the relative efficacy of bucindolol vs.
metoprolol. As clinical investigators, we are eager to take what
we've learned in GENETIC-AF and apply it to the planned Phase 3
PRECISION-AF trial."
An additional analysis of these new data
confined to patients with ejection fractions of 40% and above
showed novel evidence of a clinically significant potential
treatment effect for Gencaro in preventing and treating atrial
fibrillation in these patients. Patients with this classification
of heart failure, known as mildly reduced (HFmrEF) blending into
preserved left ventricular ejection fraction (HFpEF) HF, have few
approved or effective drug therapies. This novel result provided
the basis for a new patent issued to ARCA by the United States
Patent and Trademark Office (USPTO) in February 2021 for use of
Gencaro in treating AF in the HF population that ARCA plans to
enroll in Gencaro’s planned Phase 3 development, a population that
includes more than half of all HF patients in the United States and
Europe. The Company believes this patent would provide effective
patent coverage in the United States into 2039. ARCA has filed
similar patent applications in other countries.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “Atrial fibrillation is common in
patients with heart failure, where it complicates disease
management, and is associated with worse outcomes, including
greater rates of heart failure hospitalization, stroke, and death.
AF burden is increasingly being recognized as a more sensitive
measure of arrhythmia that is closely linked to key clinical
outcomes. In the GENETIC-AF Phase 2b clinical trial device substudy
and in the entire trial cohort, Gencaro demonstrated favorable
treatment effects compared to the comparator arm. We believe these
findings, and our observations that the AF prevention effects of
Gencaro appear to persist or be enhanced in higher LVEF HF
patients, provide the basis for the design of our Phase 3 trial,
PRECISION-AF.”
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA is developing rNAPc2 as a potential
treatment for diseases caused by RNA viruses, initially focusing on
COVID-19. The U.S. FDA has granted Fast Track designation to the
rNAPc2 development program, currently in Phase 2 clinical testing.
ARCA is also developing GencaroTM (bucindolol hydrochloride), an
investigational, pharmacologically unique beta-blocker and mild
vasodilator, as a potential treatment for 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 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 the potential future development plans for
Gencaro and rNAPc2, the expected features and characteristics of
Gencaro and rNAPc2, including the potential for genetic variations
to predict individual patient response to Gencaro, Gencaro’s
potential to treat atrial fibrillation, rNAPc2’s potential to treat
COVID-19, future treatment options for patients with COVID-19 or
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 rNAPc2 or 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, 2020, 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
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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