Core Insights - Arch Biopartners Inc. has initiated dosing in its Phase II trial for LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) with the first patient successfully dosed at Toronto General Hospital [1][9] - The trial is a multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients, with the primary objective to evaluate the incidence of acute kidney injury within seven days post cardiac surgery [4][12] - The company is expanding its clinical trial sites in Canada and the United States, with St. Michael's Hospital expected to be the next site activated [3][9] Company Overview - Arch Biopartners is focused on developing drugs targeting the dipeptidase-1 (DPEP1) pathway to prevent organ damage caused by inflammation, particularly in the kidneys, lungs, and liver [14][10] - LSALT peptide is the lead drug candidate, which has shown a strong safety profile in previous trials and aims to address the significant unmet medical need for therapies preventing CS-AKI [13][10] Trial Details - The ongoing Phase II trial involves a dosing regimen of 10mg of LSALT peptide administered intravenously twice daily for five days, with subjects randomized to receive either the peptide or a placebo [4][10] - The trial's completion is estimated for August 2026, reflecting the time required for Canadian sites to prepare and obtain necessary approvals [6] Clinical Significance - CS-AKI is a common complication in cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious health risks and increased mortality [12][8] - The LSALT peptide represents a potential first-in-class therapeutic approach to mitigate inflammation injury in this high-risk patient population [13][10]
Arch Biopartners Announces First Patient Successfully Dosed at Toronto General Hospital in Phase II Trial of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury