ARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for COVID-19
September 21 2020 - 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
has submitted an Investigational New Drug (IND) application with
the U.S. Food and Drug Administration (FDA) under the Coronavirus
Treatment Acceleration Program (CTAP) to evaluate AB201 for the
treatment of patients hospitalized with COVID-19. Pending FDA
feedback, ARCA anticipates initiating the Phase 2b portion of a
sequential Phase 2b/3 clinical evaluation of AB201 as early as the
fourth quarter of this year.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “This IND submission is a key
milestone in the clinical development of AB201. With what we
believe to be a strong scientific rationale, safety data from prior
human clinical trials in over 700 patients, and a well-defined
regulatory pathway, we believe AB201 has potential as a therapeutic
treatment for COVID-19, as well as other RNA virus associated
diseases.”
About AB201
(rNAPc2)AB201 is a small recombinant protein being
developed as a potential treatment for RNA virus- associated
disease, initially focusing on COVID-19. AB201 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 AB210 a combination of
anti-coagulant, immuno-modulation and anti-viral properties, and
therefore the potential to be effective in addressing the
pathologies caused by viral infections from multiple
aspects. AB201 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 coronavirus 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, 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 AB201 may
have important antiviral and anti-inflammatory activity in addition
to its anticoagulant effects. The Company believes that
collectively these observations provide a strong rationale for
investigating AB201 as a treatment for COVID-19 and other RNA virus
associated diseases.
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 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 atrial fibrillation (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 AB201
and Gencaro, the expected features and characteristics of AB201 and
Gencaro, including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat atrial fibrillation, AB201’s potential to treat COVID-19 or
any other RNA virus associated disease, future treatment options
for patients with COVID-19, 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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