ARCA Biopharma Announces Issuance of European Patent for Treating Cardiovascular Diseases and Conditions With a New Chemical ...
November 16 2017 - 8:30AM
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced the European Patent Office’s issuance of a patent (EPO #
2515899) on methods of treating cardiovascular disease and
conditions with a thiol-substituted isosorbide mononitrate based on
genetic targeting. The European patent, entitled “Methods and
Compositions for Cardiovascular Diseases and Conditions,” provides
protection for this novel approach to treating patients with
cardiovascular disease and conditions. The European patent
has been validated in ten countries: Denmark, France, Germany,
Ireland, Italy, Netherlands, Spain, Sweden, Switzerland and the
United Kingdom. ARCA has related patent applications pending
in the United States Patent Office and Canadian Intellectual
Property Office.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
ARCA has discovered what it believes to be a
pharmacogenetic target for AB171 that is the basis for the patents
and which the company believes may enable genetically-targeted
cardiovascular development programs. ARCA plans to advance
development of AB171, a potential New Chemical Entity (NCE), for
the treatment of two cardiovascular indications: peripheral
arterial disease (PAD) and chronic heart failure (HF). The
compound, formerly known as LA-419, was previously under
development at Lacer, S.A., where multiple Phase 1 studies were
conducted to assess pharmacokinetics and clinical tolerability.
ARCA has collaborated with Elucida Research in the
preclinical development of AB171. The Company anticipates
initiating chemistry, manufacturing and controls (CMC) activities
in the first half of 2018, followed by nonclinical studies with
AB171 to support submission of an Investigational New Drug (IND)
Application.
“ARCA was founded on the belief that a precision
medicine approach to drug development, tailoring medical treatment
to functionally important genetic variants in drug targets that
also serve as biomarkers, can enable more effective therapies,
improve patient outcomes and reduce healthcare costs. The addition
of AB171 to our genetically-targeted development pipeline,
including the Gencaro atrial fibrillation-heart failure program, is
consistent with that mission,” commented Dr. Michael Bristow,
ARCA’s President and CEO. “We believe our experience with
GENETIC-AF has established the feasibility of in-house design and
execution of pharmacogenetic clinical trials, and has provided
invaluable insights into this type of drug development. We
are eagerly anticipating the top line results of the Phase 2B
GENETIC-AF trial, expected in the latter part of the first quarter
of 2018, which following discussions with FDA, may inform further
development of Gencaro. ARCA’s current levels of staffing and
expertise allow for the simultaneous activation of the AB171
program and organization of the potential next steps for
Gencaro.”
ARCA believes that its current cash, cash
equivalents and marketable securities will be sufficient to fund
its operations, at its projected cost structure, through the end of
second quarter of 2018.
About AB171
AB171 is a thiol-containing derivative of
isosorbide mononitrate. Pre-clinical data indicate that AB171
has significant anti-oxidant properties and is favorably
differentiated from other nitrates for prevention of myocardial
remodeling, anti-atherosclerotic effects and the development of
tolerance. ARCA believes the unique pharmacology of AB171, coupled
with targeting to genetically-identified enhanced response
subpopulations, has the potential to translate to better long-term
responses than treatment with traditional pharmacotherapy.
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 and HF with reduced ejection
fraction. 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. The
Gencaro development program has been granted Fast Track designation
by the U.S. Food and Drug Administration (FDA). ARCA plans to
develop AB171, a thiol-substituted isosorbide mononitrate, as a
potential genetically-targeted treatment for PAD and for 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
anticipated characteristics of AB171 as a potential
genetically-targeted treatment for PAD and for HF, the potential
timeline for development of AB171, including any IND submission
related thereto, the potential for genetic variations to predict
individual patient response to Gencaro or AB171, Gencaro’s
potential to treat 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; 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, 2016, 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
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