ARCA Biopharma Announces Positive Outcome of End-of-Phase 2 Meeting With FDA on Gencaro Development for Atrial Fibrillation
July 31 2018 - 7:30AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced that it has received guidance from the U.S. Food and Drug
Administration (FDA) following an End-of-Phase 2 meeting regarding
the Phase 3 program for ARCA’s pharmacologically unique
beta-blocker Gencaro as a potential genetically-targeted treatment
for atrial fibrillation (AF) patients with heart failure (HF).
Based on review of the Phase 2 GENETIC-AF trial
results, as well as its alignment with previous Phase 3
pharmacogenetic substudy data, the FDA stated that data from a
single pivotal Phase 3 clinical trial may be sufficient to support
approval of Gencaro for the treatment of AF in patients with HF.
The Company, in consultation with the FDA, has established key
elements of the Phase 3 clinical trial needed to support a New Drug
Application (NDA), details of which will be confirmed via the FDA
Special Protocol Assessment (SPA) process.
The FDA previously granted the Gencaro atrial
fibrillation development program Fast Track Designation. As the
Gencaro program is developing potentially the first
genetically-targeted cardiovascular therapy, the FDA has suggested
the Company submit a SPA application, which the Company anticipates
submitting in the third quarter of 2018.
ARCA anticipates initiating the Phase 3 clinical
trial subject to securing additional financing through a strategic
partnership and/or additional sales of the Company’s
securities.
The pivotal Phase 3 clinical trial will likely
entail a single randomized, active-controlled trial with the
primary endpoint based primarily on AF Burden (AFB). AFB is defined
as the amount of time per day a patient experienced AF, as measured
by an implanted monitoring device. In the recently completed
GENETIC-AF Phase 2B clinical trial, Gencaro showed a trend for 25%
benefit over Toprol-XL in reducing AF recurrence as measured by AFB
in a subgroup of patients with implanted devices in which AFB was
monitored. For U.S. patients in this substudy, a trend for 51%
benefit was observed.
The Company believes that patients in GENETIC-AF
who had AF secondary to an underlying HF pathophysiology showed
evidence of superior benefit when treated with Gencaro compared to
Toprol-XL. In contrast, patients in GENETIC-AF who had
long-standing AF prior to the development of asymptomatic/mild HF
did not appear to show benefit when treated with Gencaro compared
to Toprol-XL (approximately 23% of the Phase 2 population).
Accordingly, in the proposed Phase 3 clinical trial, the Company
plans to exclude this non-responsive subgroup and focus on patients
who likely have AF driven by their underlying HF.
“We are encouraged by the outcome of our
End-of-Phase 2 meeting regarding the development path forward for
Gencaro and the FDA’s response to the data from our completed Phase
2B GENETIC-AF study,” commented Dr. Michael Bristow, ARCA’s
President and CEO. “FDA concurrence to proceed into Phase 3 is an
important milestone for ARCA and for patients suffering from AF and
HF, an indication for which there is a significant unmet medical
need and currently no FDA approved therapeutics.”
Updates and further details regarding the
planned Phase 3 clinical trial, including anticipated timing of
recruitment, participating centers and investigators will be
provided later this year and posted on www.clinicaltrials.gov.
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 patients
with atrial fibrillation (AF) and chronic heart failure with
reduced left ventricular ejection fraction (HFrEF) which recently
completed a Phase 2B clinical trial. 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. ARCA has a
collaboration with Medtronic, Inc. for support of the GENETIC-AF
trial. The Gencaro development program has been granted Fast Track
designation by FDA. ARCA also plans to develop AB171, a
thiol-substituted isosorbide mononitrate, as a potential
genetically-targeted treatment for peripheral arterial disease
(PAD) and for heart failure (HF). 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 or any future
clinical trials, the submission or approval of any SPA application,
potential future development plans for Gencaro, including any plans
regarding a Phase 3 clinical trial related thereto, 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 peripheral arterial disease or 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, 2017, 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
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