Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH
and OTCQB: ACHFF), announced today that patient recruitment and
dosing has begun in Turkey for the Phase II trial for LSALT peptide
targeting the prevention and treatment of cardiac
surgery-associated acute kidney injury (CS-AKI). LSALT peptide is
the Company’s lead drug candidate for preventing and treating
inflammation injury in the kidneys, lungs and liver.
There are three hospital sites in Turkey
actively screening cardiac surgery patients for this trial.
Koşuyolu Research Hospital and Kocaeli University Research Hospital
are located within and near Istanbul respectively. The third site
is Erciyes University, Faculty of Medicine Organ Transplant &
Dialysis Hospital, and is located in central Turkey. There are
three additional hospital sites in Turkey pending activation into
the trial.
The Arch Biopartners team is currently working
with hospital sites in Canada to prepare for their participation in
this Phase II trial.
The CS-AKI Phase II trial is an international
multi-center, randomized, double-blind, placebo-controlled study of
LSALT peptide. The recruitment target for the trial is 240
patients. The primary objective of the trial is to evaluate the
percentage of subjects with AKI within seven days following on-pump
(heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney
Disease: Improving Global Outcomes) criteria.
Details of the Phase II trial, entitled “Phase 2
Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of LSALT peptide for the Prevention or Attenuation of Acute
Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery”
can be viewed at clinicaltrials.gov.
Cardiac Surgery-Associated Acute Kidney
Injury (CS-AKI) and LSALT peptide
CS-AKI is often caused by ischemia-reperfusion
injury (IRI) that reduces blood flow (ischemia) and thus oxygen in
the kidney, causing kidney cell damage. Once blood flow is restored
to normal (reperfusion), inflammation is triggered and injury to
kidney cells is exacerbated. In the worst cases of AKI, kidneys
fail, leading to kidney dialysis or kidney transplant. There is no
treatment available in the market today that prevents acute kidney
injury of the type commonly experienced by on-pump cardiac surgery
patients.
LSALT peptide targets the dipeptidase-1 (DPEP-1)
pathway and has been shown by Arch scientists and their
collaborators to prevent IRI to the kidneys in pre-clinical models,
providing the scientific rationale for Arch to use LSALT peptide in
this CS-AKI trial. Details of their findings were published in a
Science Advances publication, titled “Dipeptidase-1 governs renal
inflammation during ischemia reperfusion injury” by Lau et.
al. and can be found at the following link at the journal’s
website.
Advisory services and a funding contribution
from the National Research Council of Canada Industrial Research
Assistance Program (NRC-IRAP) announced by the Company in March
2023, will significantly offset the costs of the CS-AKI Phase II
trial.
Incidence of Cardiac Surgery-Associated
Acute Kidney Injury (CS-AKI)
Acute kidney injury (AKI) is a known common
complication in patients after coronary artery bypass grafting
(CABG) and other cardiac surgeries, including on-pump surgeries
which increase the risk of AKI. The reported prevalence of CS-AKI
is up to 30% and is independently associated with an increase in
morbidity and mortality.
About Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical
trial company focused on preventing inflammation and acute organ
injury. The Company is developing new drug candidates that inhibit
inflammation in the lungs, kidneys, and liver via the dipeptidase-1
(DPEP-1) pathway and are relevant for common injuries and diseases
where organ inflammation is an unmet problem.
For more information on Arch Biopartners'
science and technologies, please visit:
www.archbiopartners.com/our-science
For investor information and other public
documents the company has also filed on SEDAR+, please visit
www.archbiopartners.com/investor-hub
The Company has 62,755,633 common shares outstanding.
For more information, please contact:
Richard MuruveChief Executive
OfficerArch Biopartners, Inc.
647-428-7031info@archbiopartners.com |
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Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of applicable Canadian securities
laws regarding expectations of our future performance, liquidity
and capital resources, as well as the ongoing clinical development
of our drug candidates targeting the dipeptidase-1 (DPEP-1)
pathway, including the outcome of our clinical trials relating to
LSALT peptide (Metablok), the successful commercialization and
marketing of our drug candidates, whether we will receive, and the
timing and costs of obtaining, regulatory approvals in Canada, the
United States, Europe and other countries, our ability to raise
capital to fund our business plans, the efficacy of our drug
candidates compared to the drug candidates developed by our
competitors, our ability to retain and attract key management
personnel, and the breadth of, and our ability to protect, our
intellectual property portfolio. These statements are based on
management’s current expectations and beliefs, including certain
factors and assumptions, as described in our most recent annual
audited financial statements and related management discussion and
analysis under the heading “Business Risks and Uncertainties”. As a
result of these risks and uncertainties, or other unknown risks and
uncertainties, our actual results may differ materially from those
contained in any forward-looking statements. The words “believe”,
“may”, “plan”, “will”, “estimate”, “continue”, “anticipate”,
“intend”, “expect” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. We undertake no
obligation to update forward-looking statements, except as required
by law. Additional information relating to Arch Biopartners Inc.,
including our most recent annual audited financial statements, is
available by accessing the Canadian Securities Administrators’
System for Electronic Document Analysis and Retrieval (“SEDAR”)
website at www.sedarplus.ca.
The science and medical contents of this release
have been approved by the Company’s Chief Science Officer
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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