ARCA biopharma Announces Submission of Patent Application to U.S. Patent and Trademark Office Covering Treatment of Atrial Fi...
May 13 2019 - 8:00AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced it recently filed a provisional patent application with
the United States Patent and Trademark Office (USPTO) covering
Gencaro’s (bucindolol hydrochloride) potential treatment effect in
preventing atrial fibrillation (AF) in patients with heart failure
(HF).
The patent application is based on recent novel
findings from the GENETIC-AF Phase 2B study of Gencaro, described
in “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a
Genotype-Defined Heart Failure Population,” published in JACC:
Heart Failure, a journal of the American College of Cardiology. The
new discoveries from the GENETIC-AF study that are covered by the
patent application include the key findings that patients who
developed AF and HF contemporaneously, and those who did not have
long-standing AF and HF, experience a stronger treatment effect
from Gencaro. Another unexpected observation from the study
that is covered by the patent application is the relationship
between Gencaro’s treatment effect for preventing AF recurrence and
left ventricular ejection fraction (LVEF), with greater treatment
effects correlating directly with increasing LVEF; and with the
strongest treatment effects observed in study populations with the
highest LVEF (LVEF ≥ 45%; n = 57; hazard ratio = 0.39; p <
0.05).
ARCA believes this clinical data may be
explained by both Gencaro’s unique mechanism of action in its drug
class, as well as by factors related to the pharmacotherapy of AF
intersecting with HF. This clinical data will be important in
guiding the planned Phase 3 development of Gencaro for the
treatment of AF in patients with HF, particularly in patients with
LVEF ≥ 40%.
ARCA believes that the findings from GENETIC-AF
in the application merit a patent. The Company believes drugs
in the beta-blocker class have not been adequately studied in HF
patients with LVEF ≥ 40%, which includes HF patients with mid-range
ejection fraction (HFmrEF) and HF patients with preserved ejection
fraction (HFpEF). HFmrEF and HFpEF represent more than half
of all heart failure and there are currently no therapies shown to
be effective for the treatment AF in these patients.
ARCA expects to file the provisional application
internationally and seek patent protection in the major
pharmaceutical markets including the United States, European Union,
Canada, Japan and China.
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. 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 or follow the Company on
LinkedIn.
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 likelihood that
any patents will be allowed based on the patent application, the
ability of ARCA’s financial resources to support its operations
through the end of the third quarter of 2019, potential future
development plans for Gencaro, 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 or PAD, 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
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