AB201 Development as a Potential Treatment for COVID-19 Receives U.S. FDA Fast Track Designation
November 24 2020 - 8:16AM
InvestorsHub NewsWire
WESTMINSTER, Colo. -- November 24, 2020 -- InvestorsHub NewsWire
-- 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 U.S. Food and Drug
Administration (FDA) has designated as a Fast Track development
program the investigation of AB201 as a potential treatment for
COVID-19. The Company intends to initiate a Phase 2b clinical trial
(ASPEN-COVID-19) of AB201 in approximately 100 patients
hospitalized with COVID-19 in December 2020, with topline trial
data anticipated in the second quarter of 2021.
According to the FDA’s Fast Track Guidance
document, Fast Track programs are designed to facilitate the
development and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs.
“Fast Track designation for the AB201 development
program is an important acknowledgement of the critical need for
treatments for hospitalized COVID-19 patients, whether effective
vaccines are approved and available or not,” said Dr. Michael
Bristow, ARCA’s President and Chief Executive Officer, who is also
an American Heart Association (AHA) funded COVID-19 investigator.
“We believe AB201’s combination of anticoagulant, anti-inflammatory
and antiviral effects may favorably impact clinical recovery of
patients hospitalized with COVID-19 and look forward to beginning
the ASPEN-COVID-19 trial to evaluate AB201’s potential efficacy in
this patient population."
Fast Track drug development designation is
included in the FDA Modernization Act of 1997 (FDAMA) as a formal
process to enhance interactions with the FDA during drug
development. A drug development program with Fast Track designation
would be eligible for consideration for some or all of the
following programs for expediting development and review: scheduled
meetings to seek FDA input into development plans, priority review
of the New Drug Application (NDA), the option of submitting
portions of an NDA prior to submission of the complete application
and potential accelerated approval. ARCA believes that AB201 is the
only anticoagulant class new chemical entity in development for
COVID-19 that has a Fast Track designation.
About AB201
AB201 is a small recombinant protein being developed as a potential
treatment for RNA virus-associated diseases, 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 AB201 a
combination of anticoagulant, anti-inflammatory and antiviral
properties, and therefore the potential to be effective in
addressing the impact of viral infections from multiple pathways.
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 biopharma
ARCA 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 pharmacogenetic treatment for atrial
fibrillation in patients with heart failure. For more information,
please visit www.arcabio.com or follow the Company on LinkedIn.
Safe Harbor Statement
This 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, the expected
features and characteristics
of AB201, AB201’s
potential to treat COVID-19,
CAC or any other RNA virus associated
disease, whether AB201 is the
only anticoagulant class new chemical entity in development for
COVID-19 that has a Fast Track
designation and future treatment
options 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 AB201 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 Cole
720.940.2163
derek.cole@arcabio.com
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