Arch Biopartners Applies to Health Canada to Conduct COVID19 Phase II Human Trial to Prevent Lung and Kidney Inflammation
April 24 2020 - 7:18AM
InvestorsHub NewsWire
TORONTO, Canada -- April 24, 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 submitted a Clinical Trial Application to Health
Canada for a Phase II human trial for its lead drug Metablok (LSALT
peptide) to prevent lung and kidney inflammation in patients with
COVID19.
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 acute respiratory distress syndrome
(ARDS) in patients infected with SARS-CoV-2 (COVID-19).
In the absence of a vaccine to prevent SARS-CoV-2 infection,
survival rates and health care system capacity could both be
improved with new treatments that target lung inflammation
experienced by patients with severe COVID19.
A secondary endpoint of the Phase II study is to prevent kidney
inflammation and injury, which also contributes to the mortality of
COVID19 patients.
As a result of clinical interest to support the Phase II trial in
the United States, Arch will be preparing an application to the
U.S. Food and Drug Administration as well as other authorities
within the American hospital system.
About COVID19
COVID19 is the disease caused by the novel coronavirus SARS-CoV-2
that emerged in China in late 2019. Patients with severe COVID19
develop progressive lung inflammation and acute respiratory
distress syndrome that often requires mechanical ventilation and
critical care. Patients with severe COVID19 also experience
multi-organ dysfunction including acute kidney injury, cardiac
failure and blood abnormalities. Currently, no vaccine or effective
antiviral drug exists for SARS-CoV-2. Treatment of COVID19 has been
primarily supportive and currently relies heavily on critical
care.
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.
In December 2019 Arch announced the successful completion of our
Phase I clinical trials of Metablok. A total of 52 healthy, normal
volunteers received dosing of Metablok during the 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.
Find out more about Metablok at –
https://bit.ly/metablok, with links to the paper in Cell, and a
new series of videos showing the effectiveness of Metablok treating
lung, kidney and liver inflammation in animal models using
real-time intravital microscopy.
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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