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Arch Biopartners Inc. (Arch), a late-stage clinical trial company, announced that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the University Health Network (UHN), Canada’s largest academic health sciences centre and a global leader in cardiac care and research. The volunteer patient completed five days of dosing as part of the company’s ongoing phase II trial evaluating LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).
Toronto General Hospital, ranked as the #3 hospital in the world and Canada’s top-ranked hospital by Newsweek in its 2025 list of the World’s Best Hospitals, is the first clinical site in Ontario to dose a patient in this trial. TGH joins the University of Calgary Hospital as the second Canadian clinical site to dose patients in this trial.
The company anticipates St. Michael’s Hospital (SMH) in Toronto will be the next Canadian site to activate and enroll patients into the study, pending approvals from Clinical Trials Ontario and SMH’s ethics board.
The Arch team continues to pursue additional clinical sites in Canada and the United States. Patient recruitment in Turkey is being limited to diversify the demographic and geographic patient data produced by the trial.
“The start of dosing at Toronto General Hospital marks an important milestone in advancing Arch’s phase II CS-AKI trial. The goal is to recruit about half of the trial’s patients in North America. Patient dosing completed in Turkey has provided a strong safety profile for LSALT peptide. This has given clinical trial teams increased confidence as new sites join the trial to test LSALT peptide’s ability to protect kidneys from acute inflammation injury,” said Richard Muruve, CEO, Arch Biopartners.
The CS-AKI phase II trial is an international, multi-centre, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. Subjects are randomized to receive either LSALT peptide (10?mg IV twice daily for five days) or placebo, consistent with previous clinical and dose-escalation trials. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
The start of the phase II CS-AKI trial and the ongoing dosing of volunteer patients has been mainly supported through non-dilutive funding grants previously disclosed by the company.
The company will update the study’s listing on ClinicalTrials.gov following today’s news regarding recruitment at Toronto General Hospital including a revised estimated trial completion date of August 2026. This update reflects the 12 to 18 months required by Canadian sites to complete preparations and obtain provincial and local ethics approvals prior to enrolling patients.
Details of the Phase II trial, titled “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.
CS-AKI often results from ischemia-reperfusion injury (IRI), which restricts blood flow and oxygen to the kidney (ischemia), leading to kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidney. 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. In the worst cases of AKI, the kidneys fail, requiring dialysis or a kidney transplant for survival.
LSALT peptide is the company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. It targets the dipeptidase-1 (DPEP1) enzyme, which is primarily expressed in the kidney, to inhibit its role in driving inflammation. Arch scientists and their collaborators have demonstrated that LSALT prevents IRI to the kidneys in pre-clinical models (video). This mechanism was first described in the journal Cell (2019), and further characterized in Science Advances (2022), by Lau et al. in a paper titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury.”
Findings from an earlier phase II trial evaluating LSALT peptide for acute lung inflammation were published in BMJ Open (2024). In that study, patients received a 5 mg daily dose of LSALT peptide. The results provided first in-human evidence validating DPEP1 as a therapeutic target for organ inflammation. The publication also reported notable biomarker findings: patients treated with LSALT peptide showed reductions in a range of inflammatory biomarkers, including a statistically significant decrease in CXCL10, a protein linked to inflammation in the lungs and kidneys. These results support continued clinical development for preventing inflammation injury in the kidneys, lungs and liver.
Acute kidney injury (AKI) is a frequent complication following cardiac surgery, especially in procedures that use a heart-lung machine. Clinical studies report that up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, a condition that increases the risk of serious complications, longer hospital stays, and increased mortality.
With no approved therapies available, CS-AKI remains an area of significant unmet medical need. LSALT peptide offers a potential first-in-class therapeutic approach to prevent inflammation injury in this high-risk population.
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury and organ damage caused by inflammation. The company is developing a platform of novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway prevalent in the kidneys, lungs, and liver.
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