ARCA biopharma Provides Update on ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 as a Potential Treatment for COVID...
July 13 2021 - 7:00AM
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 ASPEN-COVID-19, the Phase 2b clinical trial evaluating
rNAPc2 as a potential treatment for patients hospitalized with
COVID-19.
ARCA has received approval from regulatory
authorities in Argentina and Brazil to enroll patients in
ASPEN-COVID-19. The trial is currently enrolling patients at seven
investigative sites in the United States. The Company anticipates
enrolling the first South American patients in July 2021.
Trial target enrollment is being increased from
100 to 160 patients in order to maximize the sample size for
determining if there are differences in the two rNAPc2 dose
regimens being investigated, to minimize variance in the standard
of care heparin control arm, in recognition of the study now being
conducted in different geographic regions and to account for
evolving changes in the clinical course of COVID-19. To date, 77
patients have been enrolled in the trial. The Company also updated
its guidance and now anticipates topline data from this
international Phase 2b clinical trial in the fourth quarter of
2021.
“With the pandemic continuing to impact patients
around the world and the emergence of multiple variants, there
remains a 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. “Many
pathogenic viruses, including SARS-CoV-2, increase host cell
expression of tissue factor, the primary initiator of the extrinsic
coagulation pathway that also signals a parallel inflammatory
response. rNAPc2 is a high affinity inhibitor of tissue factor, and
with its combination of anticoagulant, anti-inflammatory and
potential antiviral effects, we believe 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.
Argentina and Brazil are experiencing a higher COVID-19 case rate
than the U.S. and, with their excellent investigators and track
record in clinical trials, are logical countries in which to expand
the Phase 2 trial and, ultimately, a potential Phase 3 trial.”
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 50% 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 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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