ARCA biopharma Announces Submission of PCT Patent Application for the Treatment of Coronavirus Infection and Associated Coagulopathy with rNAPc2
August 09 2021 - 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
that it has submitted a Patent Cooperation Treaty (PCT) patent
application, following on previously submitted provisional patent
applications, for the use of the Company’s developmental drug
rNAPc2 to treat patients hospitalized with COVID-19.
The patent is based on novel research
discoveries from the laboratory of Univ.-Prof. Dr. Wolfram Ruf, at
the Center for Thrombosis and Hemostasis (CTH) of the University
Medical Center Mainz, Germany. The Company believes that this
patent, if issued, could potentially provide effective market
exclusivity for rNAPc2 in certain countries for the treatment of
patients with SARS-CoV-2 infection and associated coagulopathy into
approximately 2040, if rNAPc2 is further developed and approved for
this indication. The Company plans to pursue related patent
protection in foreign jurisdictions as appropriate.
The Patent Cooperation Treaty (PCT) is an
international treaty with more than 150 Contracting States. The PCT
makes it possible to seek patent protection for an invention
simultaneously in a large number of countries by filing a single
“international” patent application instead of filing several
separate national or regional patent applications. The granting of
patents remains under the control of the national or regional
patent offices in what is called the “national phase”.
rNAPc2 is a small recombinant protein being
developed as a potential treatment for serious viral infections,
initially focusing on COVID-19. rNAPc2 is a potent, selective
inhibitor of tissue factor (TF), which has been identified as
playing a central role in the inflammatory response to viral
infections and in the process of viral dissemination. Its unique
mechanism of action gives rNAPc2 a combination of anti-coagulant,
anti-inflammatory and potential anti-viral properties, and
therefore the Company believes it may be effective in addressing
the impact of viral infections from multiple pathways. rNAPc2 has
previously undergone Phase 1 and Phase 2 testing in more than 700
patients, including in clinical studies for prevention of venous
and arterial thrombosis, where it showed efficacy in inhibiting the
TF pathway and was well tolerated at therapeutic doses. Recent
research suggests that the disease syndrome caused by SARS-CoV-2
may have much in common with other severe infections in which the
infection process causes inappropriate activation of the
coagulation system and other aspects of the immune response,
resulting in serious complications. Recent mechanistic discoveries
including research from Dr. Ruf’s laboratory as well as prior data
from studies in non-human primates (NHPs) given lethal doses of
Ebola or Marburg filoviruses demonstrating morbidity and mortality
reductions, decreases in inflammatory biomarkers and reduction in
viral load, indicate that rNAPc2 may have important antiviral and
anti-inflammatory activity in addition to its anticoagulant
effects.
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA is developing rNAPc2 as a potential
treatment for diseases caused by RNA viruses, initially focusing on
COVID-19. The U.S. FDA has granted Fast Track designation to the
rNAPc2 development program, currently in Phase 2b clinical testing
and an Orphan Drug designation for the use of rNAPc2 for the
treatment of Ebola. ARCA is also developing
Gencaro™ (bucindolol hydrochloride), an investigational,
pharmacologically unique beta-blocker and mild vasodilator, as a
potential treatment for 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 U.S. FDA has granted the Gencaro development program
Fast Track designation and a Special Protocol Assessment (SPA)
agreement. For more information, please visit www.arcabio.com or
follow the Company on LinkedIn.
Safe Harbor StatementThis 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 future development plans for rNAPc2,
the expected features and characteristics of rNAPc2, the
anticipated development timeline for rNAPc2, rNAPc2’s potential to
treat COVID-19, or any other RNA virus associated disease, whether
rNAPc2 is the only anticoagulant class new chemical entity in
development for COVID-19 Associated Coagulopathy and the potential
future treatment options and needs for patients with COVID-19. 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 rNAPc2 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, 2020, 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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