UHN Participates in Phase II LSALT Peptide Trial for Post-Cardiac Surgery AKI

Arch Biopartners, a clinical-stage company, is advancing its lead drug candidate, LSALT peptide, in a Phase II trial aimed at preventing and treating acute kidney injury (AKI) that can occur following cardiac surgery. The trial has recently welcomed the Anesthesia Clinical Trials Unit (ACTU) from the University Health Network (UHN), a leading academic research organization specializing in anesthesia and pain management, as a new participant. The LSALT peptide is designed to mitigate inflammation in vital organs such as the kidneys, lungs, and liver.

Dr. Karkouti, the director of ACTU, expressed enthusiasm for the trial's potential to alleviate the significant impact of AKI in cardiac surgery patients. The team, including Dr. Cusimano and Dr. Djaiani, is working towards obtaining the necessary institutional approvals to commence the study at Toronto General Hospital. The UHN clinical team has already applied to the local ethics board for permission to be part of the research.

With UHN on board, the number of trial sites has expanded to eight, including six active sites in Turkey. The Phase II trial is structured as an international, multi-center, randomized, double-blind, and placebo-controlled study. It aims to recruit 240 patients and will primarily assess the incidence of AKI within a week post-cardiac surgery, using criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) group.

AKI, particularly in the context of cardiac surgery, is often triggered by ischemia-reperfusion injury (IRI), which involves a reduction in blood flow to the kidneys followed by a return to normal flow that can exacerbate cell damage. Severe cases may lead to kidney failure, necessitating dialysis or transplant. Currently, no market-available treatments specifically prevent the type of AKI experienced by patients undergoing on-pump cardiac surgery.

The LSALT peptide works by targeting the dipeptidase-1 (DPEP-1) pathway, which has been shown in pre-clinical models to prevent IRI in the kidneys. The findings supporting this approach were published in Science Advances, highlighting the peptide's potential in treating CS-AKI. The National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) has provided advisory services and funding, which will significantly help offset the trial's costs.

UHN, recognized as Canada's premier hospital and a global leader in public healthcare, is home to Toronto General Hospital and several other renowned institutions. It is renowned for its extensive research and complex case management, positioning it as a hub for innovation, education, and patient care.

Arch Biopartners is dedicated to developing new drug candidates that address inflammation and acute organ injury. The company's focus is on treatments that inhibit inflammation through the DPEP-1 pathway, addressing unmet needs in conditions characterized by organ inflammation.