GENETIC-AF Clinical Trial for Prevention of Atrial Fibrillation Enrolls 50th Patient
January 12 2016 - 8:30AM
Business Wire
Enrollment for Phase 2B Interim Analysis of
Efficacy Data Expected by Year-End 2016
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today provided an update on GENETIC-AF, the Company’s
Phase 2B/3 clinical trial evaluating GencaroTM (bucindolol
hydrochloride) as a potential genetically-targeted treatment for
the prevention of atrial fibrillation.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20160112005677/en/
Dr. Michael R. Bristow, President and
CEO, ARCA biopharma, Inc. (Photo: Business Wire)
Fifty (50) patients have been enrolled in the GENETIC-AF trial.
By the end of 2016, the Company anticipates enrollment of a
sufficient number of patients for the Data Safety Monitoring Board
(DSMB) interim analysis of Phase 2B efficacy data. Allowing for
patients to complete their 24-week treatment period, the outcome of
the DSMB interim analysis is expected in the first half of
2017.
“We are pleased with the clinical investigator support for the
GENETIC-AF trial,” commented Dr. Michael Bristow, ARCA’s President
and CEO. “Under the revised trial protocol, which broadened the
target patient population, patient enrollment in the trial has
increased steadily over the past several months. We expect the DSMB
interim analysis of Phase 2B efficacy data, and the potential DSMB
recommendation to convert the trial to a pivotal Phase 3 trial, to
occur in the first half of 2017.”
There are currently 60 clinical trial sites in the United States
and Canada, with 5 additional sites in start-up.
GENETIC-AF Trial Phase 2B Projected
Timeline
• Revised protocol distributed to
participating clinical trial sites
March 2015
• GENETIC-AF Trial Investigators meeting
and training
May
• First trial sites operating under
revised protocol
May
• Approximately 65 clinical trial sites in
U.S. & Canada
Q4
• First 50 patients enrolled in trial
January 2016
- Sufficient enrollment for Phase 2B DSMB
Interim Efficacy Analysis
YE 2016
- DSMB Interim Analysis Decision
1H 2017
The Company’s forecast of the time periods to achieve these
milestones is a forward-looking statement and involves risks and
uncertainties, and actual results are likely to vary as a result of
a number of factors, including the factors discussed in “Risk
Factors” in the Company’s periodic SEC filings.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/3, multi-center, randomized,
double-blind clinical trial comparing the safety and efficacy of
Gencaro to Toprol-XL (metoprolol succinate) for the treatment of
atrial fibrillation (AF) in patients with heart failure and left
ventricular systolic dysfunction (HFREF patients). The primary
endpoint of GENETIC-AF is time to symptomatic AF/atrial flutter
(AFL). ARCA is enrolling only HFREF patients with the genetic
variant of the cardiac beta-1 adrenergic receptor, which the
Company believes responds most favorably to Gencaro, the 389
arginine homozygous genotype (ADRB1 Arg389Arg). GENETIC-AF has an
adaptive design, under which the Company initiated the trial as a
Phase 2B trial. The GENETIC-AF Data Safety Monitoring Board (DSMB)
will analyze certain data from the Phase 2B portion of the trial
and recommend, based on a comparison to the pre-trial statistical
assumptions, whether the trial should proceed to Phase 3. The
Company expects GENETIC-AF will enroll a combined 620 patients over
the Phase 2B and Phase 3 portions of the trial.
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
United States in 2010 ranged from 2.7 million to
6.1 million people. Hospitalization rates for AF increased by
23% among U.S. adults from 2000 to 2010 and hospitalizations
account for the majority of the economic cost burden associated
with AF.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160112005677/en/
ARCA biopharmaDerek
Cole720.940.2163derek.cole@arcabiopharma.com
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Apr 2023 to Apr 2024