ARCA biopharma and Medtronic to Collaborate on Atrial Fibrillation Clinical Trial for GencaroTM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular diseases,
today announced that it has entered into an agreement with Medtronic,
Inc. (NYSE:MDT), a leader in medical technologies to improve the
treatment of chronic diseases, including cardiac rhythm disorders, to
collaborate on ARCA’s proposed clinical trial, known as GENETIC-AF, of
its lead developmental drug Gencaro (bucindolol hydrochloride).
GENETIC-AF is planned as a Phase 2b/3 clinical trial comparing Gencaro
to metoprolol CR/XL for prevention of atrial fibrillation (“AF”) in
patients with heart failure and reduced left ventricular ejection
fraction ("HFREF"). ARCA plans to enroll only patients with the genetic
variant of the beta-1 cardiac receptor which the Company believes
responds most favorably to Gencaro. GENETIC-AF has an adaptive design,
under which the Company plans to initiate it as a Phase 2b study in
approximately 200 patients and then, depending on the results of an
interim analysis, expand the trial to a Phase 3 study by enrolling an
estimated additional 420 patients.
Under the collaboration, ARCA plans, with the support of Medtronic, to
conduct a substudy that will include continuous monitoring of the
cardiac rhythms of all 200 patients enrolled during the Phase 2b portion
of GENETIC-AF. Each patient will have heart rhythm monitoring via a
Medtronic device, either a previously implanted cardiac
resynchronization or defibrillation device, or a previously or newly
inserted Reveal® loop recorder. The collaboration
substudy will measure AF burden, defined as a patient’s actual time in
AF regardless of symptoms. In determining the presence of an efficacy
signal in the Phase 2b portion of the trial, AF burden will be evaluated
along with time to mortality or recurrent AF, which will also be the
Phase 3 primary endpoint.
ARCA believes that the AF burden endpoint will help provide an accurate
and comprehensive assessment of each patient’s AF episodes, and will be
useful in evaluating the relative efficacies of Gencaro and metoprolol
CR/XL. Under the collaboration, Medtronic will support the implantation
and use of the Medtronic monitoring devices, and will manage the AF
burden data collection and analysis. If GENETIC-AF proceeds to Phase 3,
the parties will seek to enroll at least 100 additional patients in the
AF burden substudy.
Dr. Michael Bristow, MD, PhD, President and Chief Executive Officer of
ARCA, said, “We are excited about our collaboration with Medtronic on
GENETIC-AF. We believe that the use of implanted, continuous monitoring
devices that allow for the more precise measurement of atrial
fibrillation represents the next generation of diagnosis and treatment
options for patients at risk for this disease. The GENETIC-AF trial has
the potential to result in an approvable new therapy that is safe and
effective for HFREF patients at high risk for atrial fibrillation.”
AF is considered an epidemic cardiovascular disease with an estimated
prevalence of at least 2.7 million Americans in 2010. The approved
therapies for the treatment or prevention of AF have certain
disadvantages in HFREF patients, such as toxic or cardiovascular adverse
effects, and most of the approved drugs for AF are contra-indicated or
have warnings in their prescribing information for such patients. ARCA
believes there is an unmet medical need for new AF treatments that have
fewer side effects than currently available therapies and are more
effective, particularly in HFREF patients.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies
for cardiovascular diseases. The Company's lead product candidate,
GencaroTM (bucindolol hydrochloride), is an investigational,
pharmacologically unique beta-blocker and mild vasodilator being
developed for atrial fibrillation. 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
atrial fibrillation prevention treatment. ARCA has a collaboration with
the Laboratory Corporation of America (LabCorp), under which LabCorp has
developed a companion genetic test for Gencaro. For more information
please visit www.arcabiopharma.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 potential for genetic variations to predict individual
patient response to Gencaro, Gencaro’s potential to treat atrial
fibrillation, future treatment options for patients with atrial
fibrillation, the role of AF burden in diagnosis and treatment of atrial
fibrillation and the potential for Gencaro to be the first
genetically-targeted atrial fibrillation 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: the Company's financial resources and
whether they will be sufficient to meet the Company's business
objectives and operational requirements; results of earlier clinical
trials may not be confirmed in future trials, the protection and market
exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual
report on Form 10-K for the year ended December 31, 2012, the Company’s
Registration Statement on Form S-1 (Registration No. 333-187508), and
subsequent filings. The Company disclaims any intent or obligation to
update these forward-looking statements.
