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 that applications to the Turkish Ministry of Health and
local Ethics Committee have been submitted to obtain permission to
recruit COVID-19 patients in Turkey for the Phase II trial of its
lead drug, LSALT peptide (Metablok).
Arch is planning to expand the existing Phase II
trial about to begin in the U.S. by adding hospital sites in
İstanbul and Ankara, Turkey. These two sites will be working
concurrently with up to three hospitals in the United States to
enroll sixty patients into the trial. The Turkish sites will follow
the same trial protocol and will be connected to the same patient
database that will be used by the American sites during the trial.
Patient data from Turkey will be admissible to the U.S. FDA,
similar to the U.S. patient data, in support of the Company’s
Investigational New Drug Application.
“We are very pleased to be working with our
Turkish collaborators and investigators to expand our patient
enrollment beyond North America for this important Phase II trial,”
said Richard Muruve, CEO of Arch.
Progress toward the start of the trial continues
in the U.S. with the dosing of the first patient expected to occur
this month. Recruitment of patients in Turkey will follow once the
trial has been approved by the Turkish regulatory authorities,
expected during the month of September.
About the Phase II trial for LSALT
Peptide
The Phase II trial will be a multicenter,
randomized, double-blind, placebo-controlled, proof of concept
study of LSALT peptide as prevention of organ inflammation known to
trigger acute respiratory distress syndrome (ARDS) and acute kidney
injury (AKI) in patients infected with SARS-CoV-2 (COVID-19).
The composite primary endpoint of the phase II
trial reflects the severe effects often experienced by hospitalized
COVID-19 patients and deemed appropriate for LSALT peptide’s novel
mechanism of action in blocking consequential inflammation in the
lungs and kidneys.
The Phase II results will be used to design a
Phase III trial, including greater patient numbers and optimal drug
dosing.
About COVID-19
COVID-19 is the disease caused by the novel
coronavirus SARS-CoV-2 that emerged in China in late 2019. Severe
complications from COVID-19 are in large part due to excessive host
immune responses to the virus that result in progressive lung
inflammation and acute respiratory distress syndrome that often
requires mechanical ventilation and critical care1. 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 nor its inflammation
complications. Treatment of severe COVID-19 has been primarily
supportive, relying heavily 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.
1 J. S. Ayres, Sci. Adv 10.1126/sciadv.abc1518 (2020)
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 pipeline of new drug
candidates that inhibit inflammation in the lungs, liver and
kidneys via the dipeptidase-1 (DPEP-1) pathway for multiple medical
indications.
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 leukocyte (white blood cell) adhesion
receptor on the lung, liver and kidney endothelium in
pre-clinical models. LSALT differs from typical anti-inflammatory
drugs by targeting this novel adhesion receptor rather than
targeting individual cytokines, of which there are over 30
currently known.
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 60,782,302 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.
The science and medical contents of this release
have been approved by the Company’s Chief Science Officer
The Company is not making any express or implied
claims that its product has the ability to eliminate, cure or
contain Covid-19 (or SARS-2 Coronavirus) at this time
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
info@archbiopartners.com
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