Arch Biopartners submits IND to the FDA for COVID-19 Phase II trial to prevent organ inflammation.
08 Juni 2020 - 2:30PM
InvestorsHub NewsWire
TORONTO, Canada -- June 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 submitted an Investigational New Drug (IND)
Application to the U.S. Food and Drug Administration (FDA) for its
lead drug Metablok (LSALT
peptide) to conduct a Phase II trial to prevent acute
organ inflammation and injury experienced by patients with
COVID-19.
The submission of the IND application was made by Arch following
several weeks of review of the Company’s Phase II plans by the FDA
under the Coronavirus Treatment Acceleration Program.
The Phase II trial, which was recently
cleared by Health Canada to proceed, will be a multicenter,
randomized, double-blind, placebo-controlled, proof of concept
study of LSALT peptide in COVID-19. The trial is expected to
commence in the summer of 2020.
The primary endpoint of the Phase II trial is a composite that
includes prevention of acute respiratory distress syndrome (ARDS),
acute kidney injury (AKI), and acute liver injury. The composite
reflects severe effects often experienced by hospitalized COVID-19
patients and Metablok’s novel mechanism of action in blocking
consequential inflammation in these organs.
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 multiple organ dysfunction including acute kidney
injury, liver dysfunction, cardiac failure, and blood
abnormalities. Currently, no approved vaccine or effective
antiviral drug exists for SARS-CoV-2. Treatment of severe COVID-19
has been primarily supportive, relying on respiratory, infectious
diseases, and critical care medicine.
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 AKI
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 pipeline to produce new drug candidates that
inhibit inflammation in the lungs, liver and kidneys caused via the
dipeptidase-1 (DPEP-1) pathway.
Metablok (LSALT peptide) 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 placebo-controlled Phase I human trial.
In all cases, Metablok was well tolerated during the 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
For more information, please contact:
Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.
647-428-7031
e. info@archbiopartners.com
ARch Biopartners (QB) (USOTC:ACHFF)
Historical Stock Chart
Von Nov 2024 bis Dez 2024
ARch Biopartners (QB) (USOTC:ACHFF)
Historical Stock Chart
Von Dez 2023 bis Dez 2024