ASPEN-COVID-19 Data and Safety Monitoring Committee Recommends Continuing Phase 2b Clinical Trial to Completion Based on Interim Analysis of Efficacy and Safety Data
October 28 2021 - 4:30PM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today provided an
update on the ASPEN-COVID-19 Phase 2b clinical trial evaluating
rNAPc2 as a potential treatment for patients hospitalized with
severe COVID-19. The Company announced that the Data and Safety
Monitoring Committee (DSMC) has completed a pre-specified interim
analysis and, based on the DSMC’s review of approximately 75% of
the projected final efficacy and safety data, recommended
completion of the clinical trial with no modifications to the trial
design. The rNAPc2 development program has been granted Fast Track
designation by the U.S. Food and Drug Administration
(FDA). The Company now anticipates completion of target
enrollment of 160 patients by year end 2021 and reporting of
topline data in the first quarter of 2022.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “Clearing the final interim analysis
with no recommended changes in the Phase 2b clinical trial design
is an important step in a clinical trial and in the development of
rNAPc2 for prevention of COVID-19-associated coagulopathy. We are
focused on finishing the clinical trial, which we estimate will
complete enrollment by year end. We look forward to sharing the
top-line trial results in the first quarter of next year and
reviewing the findings with the FDA.”
About
ASPEN-COVID-19ASPEN-COVID-19 is a Phase 2b randomized,
multi-center, international clinical trial evaluating two dose
regimens of rNAPc2 versus heparin in approximately 160 hospitalized
SARS-CoV-2 positive patients that also have an elevated D-dimer
level. The primary endpoint of the trial is the change in D-dimer
level from baseline to Day 8 relative to standard of care heparin.
D-dimer is a biomarker commonly used for assessing coagulation
activation, which is elevated in approximately 40% to 75% of
hospitalized COVID-19 patients and is associated with adverse
clinical outcomes. Heparin is an anti-coagulant
commonly given to any patient hospitalized in the United States for
COVID-19. Other objectives of Phase 2b are to assess
safety, determine the optimal dose regimen of rNAPc2 for a
potential Phase 3 clinical trial and evaluate multiple additional
clinical endpoints as detailed in the ASPEN-COVID-19 listing on
clinicaltrials.gov.
The U.S. Food and Drug Administration (FDA) has
designated the investigation of rNAPc2 as a potential treatment for
COVID-19 as a Fast Track development program. ARCA believes that
rNAPc2 is the only anticoagulant class new chemical entity in
development for COVID-19.
About rNAPc2 (AB201)rNAPc2 is a
small recombinant protein being developed as a potential treatment
for COVID-19 and potentially other viral diseases. 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 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 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 rNAPc2 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 rNAPc2 as
a treatment for COVID-19 and other 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 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 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.
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 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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