ARCA biopharma Receives FDA Fast Track Designation for Gencaro™ Atrial Fibrillation Development in a Genetically Targeted H...
April 13 2015 - 8:30AM
Business Wire
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has designated as a Fast Track development
program the investigation of GencaroTM for the prevention of atrial
fibrillation/atrial flutter in a genetically modified heart failure
population (heart failure patients with reduced left ventricular
ejection fraction, HFREF). Gencaro is the Company’s
investigational, pharmacologically unique beta-blocker and mild
vasodilator.
Dr. Michael Bristow, CEO, ARCA biopharma
(Photo: Business Wire)
According to the FDA’s Fast Track Guidance document, Fast Track
programs are designed to facilitate the development and expedite
the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to
address unmet medical needs.
Gencaro is currently being evaluated as a potential treatment
for atrial fibrillation in a genetically-defined heart failure
(HFREF) population in GENETIC-AF, a Phase 2B/3 adaptive design
clinical trial. ARCA anticipates that enrollment of approximately
200 patients in the Phase 2B portion of the trial will be completed
by the end of 2016.
“We view Fast Track designation for the Gencaro development
program as an important acknowledgement of the need for
advancements in the treatment of atrial fibrillation in heart
failure patients,” said Michael R. Bristow, President and Chief
Executive Officer of ARCA. “Atrial fibrillation afflicts over 2.7
million people in the United States with 250,000 to 500,000 new
cases diagnosed each year. We believe we have a significant
opportunity to improve the treatment options for heart failure
patients living with atrial fibrillation.”
Fast Track drug development designation was included in the FDA
Modernization Act of 1997 (FDAMA) as a formal process to enhance
interactions with the FDA during drug development. A drug
development program with Fast Track designation is eligible for
consideration for some or all of the following programs for
expediting development and review: scheduled meetings to seek FDA
input into development plans, priority review of the New Drug
Application (NDA), the option of submitting portions of an NDA for
review prior to submission of the complete application and
potential accelerated approval.
Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained cardiac
arrhythmia, is considered an epidemic cardiovascular disease and a
major public health burden. The estimated number of individuals
with AF globally in 2010 was 33.5 million. According to the 2015
American Heart Association report on Heart Disease and Stroke
Statistics, the estimated number of individuals with AF in the U.S.
in 2010 ranged from 2.7 million to 6.1 million people.
Hospitalization rates for AF increased by 23% among US adults from
2000 to 2010 and hospitalizations account for the majority of the
economic cost burden associated with AF.
AF is a disorder in which the normally regular and coordinated
contraction pattern of the heart’s two small upper chambers (the
atria) becomes irregular and uncoordinated. The irregular
contraction pattern associated with AF causes blood to pool in the
atria, predisposing the formation of clots potentially resulting in
stroke. AF increases the risk of mortality and morbidity due to
stroke, congestive heart failure and impaired quality of life. The
approved therapies for the treatment or prevention AF have certain
disadvantages in patients with heart failure and/or reduced left
ventricular ejection fraction (HFREF) patients. These include 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. The Company 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 Pharmacogenomics
Pharmacogenomics is the study of genetic polymorphisms that
underlie individual differences in responses to therapeutics drugs.
Pharmacogenomics includes identifying candidate genes and
polymorphisms, correlating these polymorphisms with possible
therapies, predicting drug response and clinical outcomes, reducing
adverse events and selection, and selecting dosing of therapeutic
drugs on the basis of genotype. One goal of pharmacogenomics is to
customize drugs for defined sub-populations of patients.
A DNA sub-study of patients from the BEST Phase 3 heart failure
mortality trial of Gencaro indicated that the combinations of
beta-1 389 and alpha-2C polymorphisms in individual patients in the
trial appeared to influence the response to Gencaro.
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 Medtronic, Inc. for
support of the GENETIC-AF trial. 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, potential timing for patient
enrollment in the GENETIC-AF trial, potential timeline for
GENETIC-AF trial activities, the sufficiency of the Company’s
capital to support its operations, 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, 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, 2014, and subsequent
filings. The Company disclaims any intent or obligation to update
these forward-looking statements.
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Investor & Media Contact:ARCA biopharma, Inc.Derek
Cole, 720-940-2163derek.cole@arcabiopharma.com
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