Arch Biopartners Inc. has announced the dosing of the first patient in Canada for its Phase II clinical trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The trial, an international, multi-center study, is currently enrolling patients at the University of Calgary Cumming School of Medicine, with plans to expand to the University Health Network and Unity Health Toronto.
Trial Design and Objectives
The Phase II trial is designed as a randomized, double-blind, placebo-controlled study with a target enrollment of 240 patients across multiple sites in Canada and Turkey. The primary endpoint is to assess the percentage of subjects who develop acute kidney injury within seven days following on-pump cardiac surgery, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. This endpoint is critical, as CS-AKI is a significant complication associated with increased morbidity and mortality.
LSALT Peptide and Mechanism of Action
LSALT peptide is Arch Biopartners’ lead drug candidate, developed to prevent and treat inflammation-related injuries in the kidneys, lungs, and liver. The peptide targets the dipeptidase-1 (DPEP1) pathway, which has been shown to play a role in ischemia-reperfusion injury. Pre-clinical studies conducted by Arch scientists and collaborators have demonstrated that LSALT peptide can prevent kidney damage in models of ischemia-reperfusion injury, providing a strong rationale for its use in the CS-AKI trial.
The Unmet Need in CS-AKI
Cardiac surgery-associated acute kidney injury is a frequent complication, particularly in patients undergoing coronary artery bypass grafting and other on-pump cardiac surgeries. The reported prevalence of CS-AKI is as high as 30%, and it is independently linked to higher rates of morbidity and mortality. CS-AKI often arises from ischemia-reperfusion injury, where restricted blood flow and oxygen to the kidney (ischemia) leads to cell damage. Upon restoration of blood flow (reperfusion), inflammation is triggered, exacerbating the injury. Currently, there is no specific therapeutic treatment available to prevent acute kidney injury of this type, highlighting a significant unmet medical need. In severe cases, acute kidney injury can lead to kidney failure, necessitating dialysis or kidney transplantation for survival.
Management Perspective
Richard Muruve, CEO of Arch Biopartners, stated, "We are happy to see the team at the University of Calgary Hospital recruit and dose the first patient in Canada for our phase II study targeting cardiac surgery-associated acute kidney injury... The start of recruitment in Calgary, followed by the activation into the study of the two Toronto hospitals, will significantly boost the momentum of the trial."
