ARCA biopharma Announces Steering Committee of Leading International Cardiology and Electrophysiology Experts for PRECISION-A...
April 23 2019 - 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 the initial members of the Steering Committee for
PRECISION-AF, the Company’s planned Phase 3 trial evaluating
Gencaro™ (bucindolol hydrochloride) as potentially the first
genetically-targeted treatment for atrial fibrillation. The
Steering Committee is comprised of experts in the field of
cardiology and electrophysiology, particularly in clinical
development. The Company anticipates additional cardiology
thought leaders joining the Steering Committee.
Stuart J. Connolly, MD, Professor Emeritus,
Division of Cardiology at McMaster University in Hamilton, Ontario,
and William T. Abraham, MD, College of Medicine Distinguished
Professor, Division of Cardiovascular Medicine at The Ohio State
University Wexner Medical Center, have been appointed co-Chairs of
the Steering Committee.
“We are thrilled to have such a distinguished
group of clinicians and researchers participate on the PRECISION-AF
Steering Committee,” said Dr. Michael R. Bristow, President and
Chief Executive Officer of ARCA. “This committee consists of
experts in the fields of cardiology and electrophysiology, giving
our anticipated PRECISION-AF clinical trial the benefit of
experienced leadership that is at the forefront of clinical
research for the treatment of heart failure patients who have
concomitant atrial fibrillation.”
“I’m pleased to participate in this very well
designed and scientifically valid trial,” said Dr. Connolly.
"Atrial fibrillation is a growing problem where current medical
therapy does not provide adequate treatment, particularly in heart
failure populations for which there are few therapeutic
options. I look forward to working with the team at ARCA to
advance this potential new treatment for heart failure patients
living with atrial fibrillation.”
Dr. Abraham said, “I am pleased to be closely
involved with the anticipated PRECISION-AF trial, which we believe
has the potential to be the first Phase 3 cardiovascular trial to
prospectively demonstrate superior efficacy based on patient
genotype. PRECISION-AF has the potential to demonstrate efficacy in
heart failure with mid-range ejection fraction – a population with
high unmet medical need and few therapeutic options that has been
excluded from previous heart failure and atrial fibrillation
trials.”
Additional Steering Committee members are:
- Inder Anand, MD – Professor of Medicine, University of
Minnesota Medical School and VA Medical Center Minneapolis;
- A. John Camm, MD – Professor of Clinical Cardiology at St
George’s University of London, London, United Kingdom;
- Jeff S. Healey, MD – Population Health Research Institute,
McMaster University;
- Jonathan P. Piccini, MD – Director, Cardiac Electrophysiology
Clinical Trials Program, Duke University Medical Center and Duke
Clinical Research Institute;
- Michiel Rienstra, MD, PhD – University Medical Center
Groningen, The Netherlands;
- Dirk J. van Veldhuisen, MD, PhD – Chairman of Cardiology at the
University Medical Center Groningen, The Netherlands;
- Michel White, MD – Director of the Heart Failure Research Group
at the Montreal Heart Institute; and,
- Stephen B. Wilton, MD – Libin Cardiovascular Institute of
Alberta, University of Calgary.
The Steering Committee will provide scientific
oversight of PRECISION-AF and communicate its recommendations
regarding trial conduct to the trial’s Data Safety Monitoring
Board.
PRECISION-AF Clinical Trial
PRECISION-AF is designed as a single, adequate
and well-controlled Phase 3 clinical trial that may be sufficient
to support a New Drug Application (NDA) submission for an AF
indication if the objectives of the trial are achieved consistent
with the requirements of Special Protocol Assessment (SPA)
agreement with the U.S. Food and Drug Administration (FDA). The
trial is designed as a double-blind, active-controlled,
multicenter, international study comparing Gencaro with Toprol-XL
(metoprolol succinate) for the prevention of AF recurrence or
all-cause mortality (ACM) in HFmrEF patients. HFmrEF is
defined as HF with a left ventricular ejection fraction (LVEF) ≥
40% and < 50%, which constituted approximately half of the
enrolled population in the previous Phase 2 GENETIC-AF trial.
PRECISION-AF is designed to enroll approximately 400 patients who
have: HFmrEF, a recent AF event, and the genotype which responds
most favorably to Gencaro. The primary endpoint of the trial
will be time to first event of atrial fibrillation/atrial flutter
(AF/AFL) or ACM during the 26-week Follow-up Period. In the
recently completed GENETIC-AF trial, Gencaro showed a 58% treatment
benefit compared to Toprol-XL in reducing AF recurrence in the
HFmrEF population targeted for Phase 3 (hazard ratio = 0.42; 95%
CI: 0.21, 0.86; p = 0.017). With 400 patients (200 per arm) the
trial will have 90% power at a p-value of 0.01 to detect a 45%
treatment benefit for Gencaro compared to Toprol-XL. Subject to
securing additional financing, ARCA anticipates initiating
PRECISION-AF in the fourth quarter of 2019.
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 atrial
fibrillation in heart failure patients with mid-range ejection
fraction. 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 heart failure and peripheral
arterial disease (PAD). 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
the second quarter of 2019, potential future development plans for
Gencaro, including statements regarding the anticipated
PRECISION-AF trial, 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, 2018, 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
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Aug 2024 to Sep 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Sep 2023 to Sep 2024