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Highlights
- Ethics approval granted to add St. Michael’s Hospital to Arch Biopartners’ Phase II LSALT peptide trial.
- St. Michael’s Hospital will become the ninth global trial site and the fourth within a major Canadian academic hospital network.
- The LSALT peptide is being evaluated in a multi-center, double-blind Phase II study targeting a major unmet need in cardiac surgery patients.
- Up to 30% of on-pump cardiac surgery patients develop CS-AKI, with no approved preventive therapies currently available.
Arch Biopartners Inc. (TSXV:ARCH) (OTCQB:ACHFF) has received ethics approval from the University Health Network Research Ethics Board (UHN REB) for St. Michael’s Hospital, part of Unity Health Toronto, to participate in the company’s ongoing multi-center, double-blind, placebo-controlled Phase II clinical trial of LSALT peptide. The study is evaluating LSALT as a potential therapy to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).
New Clinical Site Approved
The UHN REB approval was issued through the Clinical Trials Ontario (CTO) Stream system. With this clearance in place, St. Michael’s Hospital will proceed with remaining operational requirements, including site initiation and training, prior to enrolling patients.
Once activated, St. Michael’s Hospital will become the ninth clinical site globally and the fourth site within a major Canadian academic hospital network, further strengthening the study’s clinical footprint.
Trial Progress Across Canada
Patient enrolment continues at other active trial sites, including Toronto General Hospital in Ontario and the University of Calgary Cumming School of Medicine in Alberta. At Royal Columbian Hospital in British Columbia, the research team has received ethics approval and is preparing for site initiation activities.
The company is also reviewing additional hospitals in both Canada and the United States for potential inclusion as the CS-AKI Phase II trial advances.
Phase II CS-AKI Study Details
CS-AKI and LSALT Peptide
AKI is a common complication following cardiac surgery, particularly procedures involving a heart-lung machine. CS-AKI often results from ischemia-reperfusion injury (IRI), which restricts blood flow and oxygen to the kidney (ischemia), leading to kidney cell damage. There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.
Clinical studies indicate that up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, which is associated with longer hospital stays, higher mortality risk and increased complications.
LSALT is the company’s lead drug candidate that binds to the dipeptidase-1 (DPEP1) enzyme, which is expressed in the kidneys and involved in inflammatory pathways. Preclinical research has shown that LSALT can prevent ischemia-reperfusion injury in kidney in pre-clinical models.
Prior Clinical and Scientific Evidence
Earlier Phase II findings evaluating LSALT peptide in acute lung inflammation were published in BMJ Open in 2024. That study reported reductions in range of inflammatory biomarkers in patients treated with LSALT peptide, including a statistically significant decrease in CXCL10, a protein linked to inflammation injury in the lungs and kidneys.
These results support LSALT’s proposed mechanism of action and its continued development as a potential therapy for preventing inflammation injury in critical organs.
ARCH shares last traded at CAD 1.26 per share on December 16, 2025.
