ARCA biopharma Announces rNAPc2 COVID-19 Patent Assignment Agreement
July 07 2021 - 8:00AM
ARCA biopharma, Inc. (Nasdaq: ABIO) today announced it has entered
into a patent assignment agreement with the University Medical
Center of Johannes Gutenberg University Mainz, Germany. Under the
agreement, ARCA receives exclusive world-wide patent rights to the
use of rNAPc2 as a potential treatment for COVID-19, and other
indications, based on the research and discoveries from the
laboratory of Univ.-Prof. Dr. Wolfram Ruf, the Scientific Director
and Alexander von Humboldt Professor at the Center for Thrombosis
and Hemostasis (CTH) of the University Medical Center Mainz.
rNAPc2 is a recombinant protein therapeutic
being developed by ARCA as a potential treatment for COVID-19 and
other severe viral infections. ASPEN-COVID-19 is an
on-going Phase 2b clinical trial evaluating rNAPc2 as a potential
treatment for patients hospitalized with COVID-19. The U.S. Food
and Drug Administration (FDA) designated the investigation of
rNAPc2 as a potential treatment for COVID-19 as a Fast Track
development program.
Univ.-Prof. Dr. Ruf commented, “We believe our
research, combined with the accumulating evidence on the clinical
importance of large and small vessel thromboses in COVID-19
infected patients, points to a potentially important role for the
tissue factor pathway in viral infection, inflammatory response and
the development of coagulopathy. Based on its unique modulation of
the tissue factor pathway and the evidence from its prior
development, we believe rNAPc2 has the potential to be a beneficial
therapy for patients with COVID-19.”
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “We are delighted to continue our
collaboration with Dr. Ruf and the researchers at the University
Medical Center Mainz to advance the development of rNAPc2 as a
potential treatment for patients hospitalized with COVID-19.
Despite the availability of vaccines and with the emergence of
multiple variants, patients around the world continue to experience
severe cases of COVID-19 that require hospitalization. We believe
rNAPc2’s combination of anticoagulant, anti-inflammatory and
antiviral properties give it the potential to be effective in
addressing the impact of COVID-19 from multiple pathways. As a
potential therapeutic aimed at a host response to a disease
syndrome, we believe rNAPc2 has therapeutic potential to be used
for future viral outbreaks beyond the current pandemic, even as
safe and effective vaccines for SARS-CoV-2 are successfully
deployed.”
Under the Agreement with the University Medical
Center Mainz, ARCA also obtains an option to acquire world-wide
patent rights to discoveries related to the use of rNAPc2 as a
potential therapeutic for auto-immune disorders such as systemic
lupus erythematosus, that involve the presence of anti-phospholipid
antibodies linked to tissue factor, as well as the option to
acquire patent rights for discoveries relating to other therapeutic
uses of rNAPc2. Under the Agreement, ARCA has potential upfront and
milestone obligations that could total approximately €1.6 million
and royalty obligations in the low single digit range, if rNAPc2
receives regulatory approval and is commercialized.
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 severe viral infections, initially focusing on
COVID-19. The U.S. FDA has granted Fast Track designation to the
rNAPc2 development program, currently in Phase 2 clinical testing.
ARCA is also developing GencaroTM (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.
About the University Medical Center of
the Johannes Gutenberg University MainzThe University
Medical Center of the Johannes Gutenberg University Mainz is the
only medical institution of supra-maximum supply in the German
state of Rhineland-Palatinate and an internationally recognized
science location. Medical and scientific specialists at 60 clinics,
institutes and departments work interdisciplinarily to treat more
than 350,000 patients per year. Highly specialized patient care,
research and teaching are inseparably intertwined. Around 3,400
medicine and dentistry students as well as more than 600 future
medical, commercial and technical professionals are trained in
Mainz. With a workforce of approximately 8,500 colleagues the
University Medical Center Mainz is one of the largest employers in
the region and an important driver of growth and innovation. Find
more information online at www.unimedizin-mainz.de.
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
and Gencaro, the expected features and characteristics of rNAPc2 or
Gencaro, including the potential for rNAPc2 to treat COVID-19, the
potential for genetic variations to predict individual patient
response to Gencaro, Gencaro’s potential to treat AF, future
vaccines and/or treatment options for patients with COVID-19,
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 rNAPc2 or 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, 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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