Arch Biopartners Announces Ethics Approval for St. Michael’s Hospital to Participate in the Phase II Cardiac Surgery-Associated AKI Trial for LSALT Peptide

Core Insights - Arch Biopartners Inc. has received ethics approval from the University Health Network Research Ethics Board for St. Michael's Hospital to participate in the Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD), with a pipeline targeting inflammation- and toxin-related kidney injury [17] Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients, where subjects will receive either LSALT peptide (10mg IV twice daily for five days) or placebo [5] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by KDIGO criteria [5][6] Current Status of the Trial - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network, with operational approvals and training underway before patient enrollment [2][4] - Other sites, including Toronto General Hospital and the University of Calgary, are actively enrolling patients, while Royal Columbian Hospital has received REB approval and is preparing for site initiation [4] Medical Context - CS-AKI is a common complication following cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious complications and increased mortality [11][12] - There are currently no approved therapies for CS-AKI, highlighting a significant unmet medical need that LSALT peptide aims to address [12] Mechanism of Action - LSALT peptide is designed to prevent inflammation injury in the kidneys, lungs, and liver by binding to the dipeptidase-1 (DPEP1) enzyme, which plays a role in triggering organ inflammation [8] - Pre-clinical models have demonstrated LSALT's ability to prevent ischemia-reperfusion injury to the kidneys, supporting its therapeutic potential [8] Previous Research Findings - An earlier Phase II trial for acute lung inflammation showed that patients treated with LSALT peptide had significant reductions in inflammatory biomarkers, validating DPEP1 as a therapeutic target [9]