Arch Biopartners Inc. announced that the University Health Network Research Ethics Board, through the Clinical Trials Ontario Streamlined Research Ethics Review System, has granted provincial ethics approval for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical teams at Toronto General Hospital and St. Michael's Hospital in Toronto are now seeking final internal approvals and completing final preparations to begin patient recruitment in the first quarter of 2025.

The trial continues to recruit patients at the University of Calgary Hospital and five clinical sites in Turkey. The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. 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.

Cardiac surgery-associated acute kidney injury (CS-AKI) is often caused by ischemia-reperfusion injury (IRI), which reduces blood flow (ischemia) and oxygen to the kidneys, causing kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidneys. Currently, no therapeutic treatment is available to prevent acute kidney injury (AKI) of the type commonly experienced by on-pump cardiac surgery patients.

In severe cases of AKI, kidney failure occurs, requiring kidney dialysis or kidney transplant for survival. LSALT peptide is Arch's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in the current CS- AKI trial.

Details of their findings were published in the journal Science Advances, titled Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury by Lau et al. and can be found, along with the latest peer-reviewed publications about DPEP1 and LSALT peptide on the Company's website. CS-AKI is a common complication in patients following coronary artery bypass grafting (CABG) and other cardiac surgeries, particularly on-pump procedures, which significantly elevate the risk of AKI.

The reported prevalence of CS-AKI is up to 30% and is independently associated with increased morbidity and mortality.