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, being conducted at the University of Calgary Cumming School of Medicine, marks a significant step in the development of a potential therapeutic for this common and serious complication of cardiac surgery.
The Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy of LSALT peptide in preventing or attenuating acute kidney injury (AKI) in patients undergoing on-pump cardiac surgery. The trial aims to recruit 240 patients across multiple sites, including the University Health Network and Unity Health Toronto, which are in the final stages of obtaining ethics and hospital approvals to commence patient recruitment.
Trial Design and Objectives
The primary objective of the Phase II trial is to evaluate the percentage of subjects who develop AKI within seven days following on-pump cardiac surgery, based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. This rigorous endpoint will provide critical data on the potential of LSALT peptide to mitigate the risk of AKI in this vulnerable patient population. The trial is registered on clinicaltrials.gov.
LSALT Peptide and CS-AKI
CS-AKI often arises from ischemia-reperfusion injury (IRI), a process involving restricted blood flow and oxygen supply to the kidney during surgery, followed by inflammation upon restoration of blood flow. Currently, there are no approved therapies 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, Arch Biopartners' lead drug candidate, targets the dipeptidase-1 (DPEP1) pathway, aiming to prevent inflammation-related injury in the kidneys, lungs, and liver. Preclinical studies have demonstrated the peptide's ability to prevent IRI in the kidneys, providing a strong scientific rationale for its use in the CS-AKI trial. These findings were published in Science Advances by Lau et al., highlighting the role of DPEP1 in renal inflammation during ischemia-reperfusion injury.
The Burden of CS-AKI
Acute kidney injury (AKI) is a frequent complication in patients undergoing coronary artery bypass grafting (CABG) and other on-pump cardiac surgeries. Studies indicate that the prevalence of CS-AKI can reach up to 30%, and it is independently associated with increased morbidity and mortality. The development of effective preventive strategies is therefore of paramount importance to improve outcomes for these patients.
Management Perspective
"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 CS-AKI," said Richard Muruve, CEO of Arch Biopartners. "Our five clinical sites in Turkey have made good recruitment progress and have done a great job executing the trial to date. 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."
