Arch Biopartners Receives Health Canada Approval for COVID-19 Phase II Human Trial
08 Mai 2020 - 2:03PM
InvestorsHub NewsWire
TORONTO, Canada -- May 8, 2020 -- InvestorsHub NewsWire -- Arch
Biopartners Inc., (“Arch” or the “Company”) (TSX
Venture: ARCH and
OTCQB: ACHFF) a clinical stage company developing new drug
candidates for treating organ damage caused by inflammation, today
announced it has received a No Objection Letter from Health Canada
to conduct a Phase II human trial for its lead drug LSALT peptide
(Metablok)
to prevent organ inflammation experienced by patients with
COVID-19.
The Phase II trial will be a multicenter, randomized, double-blind,
placebo-controlled, proof of concept study of LSALT peptide. The
primary endpoint is to prevent the development of life threatening
acute respiratory distress syndrome (ARDS) in patients early in the
course of COVID-19.
A secondary endpoint of the Phase II trial is to prevent kidney
inflammation and injury, which also contributes to mortality and
occurs in up to 30% of patients with severe COVID-19.
The trial will begin with the enrolment of 60 hospitalized
patients who will receive either LSALT peptide or drug-free saline
daily for up to 14 days. There will be an option to expand the
study to include a larger number of subjects.
As a result of clinical interest to support the Phase II trial
in the United States, Arch continues to be in dialogue with the
U.S. Food and Drug Administration to obtain permission to recruit
patients at American clinical sites into the trial.
About COVID-19
COVID-19 is the disease caused by the novel coronavirus
SARS-CoV-2 that emerged in China in late 2019. Patients with severe
COVID-19 develop progressive lung inflammation and acute
respiratory distress syndrome that often requires mechanical
ventilation and critical care. Patients with severe COVID-19 also
experience multi-organ dysfunction including acute kidney injury,
liver dysfunction, cardiac failure and blood abnormalities.
Currently, no vaccine or effective antiviral drug exists for
SARS-CoV-2. Treatment of COVID-19 has been primarily supportive,
relying on critical care physicians.
Survival rates and health care system capacity could both be
improved with new treatments that prevent the severe manifestations
of COVID-19, such as worsening lung inflammation (ARDS) and acute
kidney injury experienced by patients infected with SARS-CoV-2.
About Arch
Biopartners
Arch Biopartners Inc. is a clinical stage company focused on the
development of innovative technologies that have the potential to
make a significant medical or commercial impact. Arch is developing
a drug library to produce new drug candidates that inhibit
inflammation in the lungs, liver and kidneys caused via the
dipeptidase-1 (DPEP-1) pathway.
Metablok is a novel peptide drug candidate and the lead DPEP-1
inhibitor in the Arch development pipeline. In August 2019, a
scientific team led by Arch scientists Dr. Donna Senger and Dr.
Stephen Robbins published a paper in the
journal Cell describing a novel mechanism of
action for organ inflammation. In the publication, DPEP-1 was
identified for the first time as a major neutrophil (white blood
cell) adhesion receptor on the lung, liver and
kidney endothelium.
A total of 40 out of 52 healthy, normal volunteers received
Metablok during the recent Phase I human trial. In all cases,
Metablok was well tolerated during this placebo-controlled trial
and no significant drug-related adverse effects were observed.
Continuing under development in the Arch portfolio are: AB569, a
potential new treatment for antibiotic resistant bacterial
infections in the lung and wounds; and, ‘Borg’ peptide coatings
that increase corrosion resistance and decrease bacterial biofilm
on various medical grade metals and plastics.
For more information on Arch Biopartners, its technologies and
other public documents Arch has filed on SEDAR, please visit
www.archbiopartners.com
The Company has 59,882,302 common shares outstanding.
Forward-Looking Statements
All statements, other than statements of historical fact, in
this news release are forward looking statements that involve
various risks and uncertainties, including, without limitation,
statements regarding the future plans and objectives of the
Company. There can be no assurance that such statements will prove
to be accurate. Actual results and future events could differ
materially from those anticipated in such statements. These and all
subsequent written and oral forward-looking statements are based on
the estimates and opinions of management on the dates they are made
and are expressly qualified in their entirety by this notice. The
Company assumes no obligation to update forward-looking statements
should circumstances or management’s estimates or opinions
change.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release
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