ARCA biopharma Announces Enrollment of First International Patient in Phase 2b Clinical Trial Evaluating rNAPc2 as a Potential Treatment for COVID-19
September 16 2021 - 8:30AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today announced
that the first international patient has been enrolled in
ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a
potential treatment for patients hospitalized with COVID-19. The
patient was enrolled in Brazil. ARCA also plans to enroll patients
from Argentina and is currently enrolling patients at multiple
sites in the United States. The international Phase 2b trial is
approximately 75% enrolled as of this date. The Company currently
anticipates topline trial data in the fourth quarter of 2021.
“The expansion of ASPEN-COVID-19 to trial sites
in South America and the enrollment of the first patient in Brazil
add further momentum to rNAPc2’s clinical development focused on
addressing the critical need for safe, efficacious treatments for
hospitalized COVID-19 patients,” said Dr. Michael Bristow, ARCA’s
President and Chief Executive Officer, who is also an American
Heart Association (AHA) funded COVID-19 investigator. “With its
combination of anticoagulant, anti-inflammatory and potential
antiviral effects, rNAPc2 may favorably impact clinical recovery of
patients hospitalized with COVID-19, and thus has the potential to
be a uniquely beneficial therapy for these patients, and possibly
for other virus associated diseases as well. We look forward to
working with the excellent investigators at our trial sites in
Argentina and Brazil and, assuming enrollment continues to go well,
to sharing the results of this important study in the fourth
quarter.”
ASPEN-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.
Other objectives of Phase 2b are to assess safety and determine the
optimal dose regimen of rNAPc2 for Phase 3. 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 directly associated with adverse clinical
outcomes.
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 RNA virus- associated diseases, 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 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 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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