ARCA biopharma, Inc. (Nasdaq: ABIO) today announced a new
development program to evaluate AB201 (rNAPc2), a potent, selective
inhibitor of tissue factor (TF), as a potential treatment for
COVID-19 associated coagulopathy (CAC) and the related inflammatory
response. CAC is one of the most serious adverse effects seen in
COVID-19 patients. AB201 has previously undergone clinical testing
through Phase 2 in more than 700 patients for other indications,
generating substantial safety data, which the Company believes may
enable more rapid development. ARCA anticipates filing an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) in the third quarter and initiating
late-stage clinical testing in the second half of this year.
TF is the protein responsible for initiating the
primary or extrinsic coagulation pathway. TF has been identified as
playing a central role in the inflammatory response to viral
infections and in the process of viral dissemination. AB201
(rNAPc2), a single-chain, 85 amino acid, recombinant protein, has
previously undergone Phase 1 and Phase 2 testing in more than 700
patients, including as an anti-thrombotic agent in the setting of
acute myocardial infarction (MI), 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
coronavirus may have much in common with other coagulopathic
disorders in which the blood's ability to coagulate (form clots) is
impaired by consumption of clotting factors (disseminated
intravascular coagulation, DIC). For example, filovirus infections
such as Ebola and other hemorrhagic fevers are characterized by
dysregulated activation of the TF pathway, resulting in abnormal
systemic coagulation and related inflammation, leading to organ
failure and mortality. Recent mechanistic discoveries, as well as
data from studies in non-human primates (NHPs) given lethal doses
of Ebola or Marburg filoviruses demonstrating mortality reductions,
decreases in inflammatory biomarkers and reduction in viral load,
indicate that AB201 may have important antiviral and
anti-inflammatory activity in addition to its anticoagulant
effects. Collectively, the Company believes these observations
provide a strong rationale for investigating AB201 as a treatment
for COVID-19, the disease caused by SARS CoV-2 virus.
COVID-19 disease is associated with a
significant incidence of coagulation-related adverse events,
including stroke, MI (i.e., heart attack), pulmonary emboli, and
disseminated intravascular coagulation (DIC), a condition in which
small blood clots develop throughout the bloodstream. A commonly
used biomarker for assessing coagulation activation is a D-dimer
test, which is elevated in approximately 50% of hospitalized
COVID-19 patients and is directly associated with adverse clinical
outcomes. In Ebola or Marburg NHP models, AB201 inhibited the DIC
process, as measured by lowered D-dimer levels, which the Company
believes provides further support for its therapeutic potential for
CAC. The Company believes the efficacy of AB201 against COVID-19
disease may not be affected by potential mutations of the SARS
CoV-2 virus, would be additive with therapeutics inhibiting
virus-cell binding or viral RNA polymerase, and could be effective
against other coagulopathy-associated viruses.
Dr. Wolfram Ruf, Scientific Director of the
Center for Thrombosis and Hemostasis at the Johannes Gutenberg
University Medical Center Mainz, Germany, and Professor at Scripps
Research, La Jolla, CA, commented, “Our research, combined with the
accumulating evidence on the clinical importance of large and small
vessel thromboses in the 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. With its properties in modulating the TF pathway and
the evidence from its prior development, rNAPc2 has the potential
to be a uniquely beneficial therapy for patients with
COVID-19.”
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, who is also an American Heart Association (AHA)
funded COVID-19 investigator, commented, “During this global health
crisis, we believe it is important to rapidly and collaboratively
evaluate multiple technologies to address COVID-19 and the
associated pathologic host responses. The combination of
anticoagulation, anti-inflammatory effects and antiviral activity
have the potential to make AB201 a unique therapeutic to treat
patients afflicted with COVID-19 while vaccine development is
underway and for patients for whom a vaccine is not effective. We
believe this therapeutic approach may also have potential to
address future outbreaks of diseases related to other RNA
viruses.”
Next Steps:
- The Company anticipates filing an IND application for AB201 as
a potential treatment for COVID-19 with the FDA in the third
quarter of this year.
- In collaboration with the Colorado Prevention Center, the
University of Colorado's Academic Research Organization directed by
Marc Bonaca, MD, a vascular and anti-coagulation clinical trialist,
a Phase 2B/3 clinical trial protocol is being developed for
hospitalized COVID-19 patients with elevated D-dimer levels.
- Pending FDA concurrence and obtaining trial funding, ARCA
estimates initiating late-stage clinical testing of AB201 in the
second half of 2020.
Dr. Bonaca commented, “The thrombotic
complications of COVID-19 are severe and stem directly from viral
activity and vascular inflammation. By targeting tissue factor and
the extrinsic pathway, AB201 may offer a unique approach that could
simultaneously reduce the severity of the viral infection as well
as reduce the risk of its thrombotic complications. The extensive
Phase 2 safety experience in other diseases could enable more rapid
development via a Phase 2B-Phase 3 adaptive program."
AB201 is manufactured using a proven process
that enables production at commercial scale, should clinical
testing provide sufficient evidence of efficacy to seek regulatory
approval.
About the Novel Coronavirus SARS-CoV-2
(and COVID-19 Disease)SARS-CoV-2 is a new coronavirus
identified in late 2019 and belongs to a family of enveloped RNA
viruses that include Middle East Respiratory Syndrome (MERS) and
Severe Acute Respiratory Syndrome (SARS-CoV), both of which caused
serious human infections of respiratory system. The disease caused
by the SARS-CoV-2 virus has been designated COVID-19. Since this
outbreak was first reported in late-2019, the virus has infected
over 5.4 million people and has caused over 349,000 reported deaths
(as of May 27, 2020). It has been declared a pandemic by the World
Health Organization. Currently there is no vaccine or curative drug
therapy for COVID-19.
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 AB201 as a potential
treatment for diseases caused by RNA viruses, initially focusing on
COVID-19. 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 the ability of ARCA’s financial resources to
support its operations through the end of the third quarter of
2020, potential future development plans for AB201 and Gencaro, the
expected features and characteristics of AB201 or Gencaro,
including the potential for AB201 to treat COVID-19/CAC, 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 AB201 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, 2019, 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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