Arch Biopartners Inc. has announced that Alberta Health Services (AHS) has approved its Phase II clinical trial for LSALT peptide, aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI). This development marks a significant step forward in addressing a critical unmet need in patients undergoing cardiac surgery.
The clinical team at the University of Calgary Cumming School of Medicine is finalizing preparations to begin patient recruitment in September. Additionally, University Health Network and Unity Health Toronto are securing final approvals to initiate recruitment at Toronto General Hospital and St. Michael’s Hospital, respectively. The trial is already underway at five clinical sites in Turkey.
Trial Design and Objectives
The Phase II trial is designed as an international, multi-center, randomized, double-blind, placebo-controlled study. It aims to enroll 240 patients to evaluate the efficacy of LSALT peptide in preventing AKI following on-pump cardiac surgery. The primary objective is to determine the percentage of subjects who develop AKI within seven days post-surgery, based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Detailed information about the trial can be found at clinicaltrials.gov under the title "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."
LSALT Peptide and CS-AKI
CS-AKI is frequently caused by ischemia-reperfusion injury (IRI), which occurs when blood flow and oxygen are reduced to the kidney during surgery (ischemia), leading to kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating the injury. Currently, there are no approved therapeutic treatments specifically designed to prevent AKI in on-pump cardiac surgery patients. In severe cases, AKI can lead to kidney failure, necessitating dialysis or kidney transplantation.
LSALT peptide is Arch Biopartners' lead drug candidate, targeting inflammation-related injuries in the kidneys, lungs, and liver. It acts on the dipeptidase-1 (DPEP1) pathway. Pre-clinical studies conducted by Arch scientists and collaborators have demonstrated that LSALT peptide can prevent IRI to the kidneys, providing a strong rationale for its use in the CS-AKI trial. These findings were published in Science Advances in a paper titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et al.
The Burden of CS-AKI
Acute kidney injury is a common complication following coronary artery bypass grafting (CABG) and other cardiac surgeries, particularly those involving on-pump procedures. The reported prevalence of CS-AKI is as high as 30%, and it is independently associated with increased morbidity and mortality, highlighting the urgent need for effective preventive strategies.
