Arch Biopartners Announces Toronto General Hospital Ethics Board Approval to Join the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI)

Core Viewpoint - Arch Biopartners Inc. has received ethics approval for its Phase II trial of LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Group 1: Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients [3] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, based on KDIGO criteria [3][4] Group 2: Recruitment and Locations - Toronto General Hospital is the seventh site activated globally and the second in Canada for patient recruitment [2] - The company plans to reduce recruitment in Turkey and increase it in Canada to enhance the trial's geographic and demographic data [2] Group 3: Background on CS-AKI and LSALT Peptide - CS-AKI is often caused by ischemia-reperfusion injury, leading to kidney cell damage, with no current therapeutic treatments available for this condition [5][6] - LSALT peptide is the lead drug candidate targeting the DPEP1 pathway, showing promise in preventing ischemia-reperfusion injury in pre-clinical models [6][8] Group 4: Incidence and Impact of CS-AKI - The prevalence of CS-AKI can be as high as 30% in patients undergoing on-pump cardiac surgeries, which is associated with increased morbidity and mortality [7]