Arch Biopartners Announces St. Michael’s Hospital Commences Patient Dosing in the Phase II CS-AKI Trial of LSALT Peptide

Core Viewpoint - Arch Biopartners Inc. has initiated patient dosing in a Phase II trial for LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) at St. Michael's Hospital, marking a significant step in the company's clinical development efforts [1][2]. Group 1: Trial Progress and Recruitment - St. Michael's Hospital is the third Canadian site to recruit patients for the CS-AKI Phase II trial, joining Toronto General Hospital and the University of Calgary [2]. - The trial aims to recruit a total of 240 patients, with subjects receiving either LSALT peptide (10mg IV twice daily for five days) or a placebo [7]. - The company is in discussions to expand the trial to additional cardiac surgery centers in Canada and the U.S. to enhance clinical awareness and patient recruitment [4][5]. Group 2: Safety and Efficacy Data - A blinded review of trial data indicates that acute kidney injury (AKI) has been consistently observed, supporting the trial's design and endpoints, with no adverse events related to LSALT peptide reported [3]. - The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days post on-pump cardiac surgery, as defined by KDIGO criteria [7]. Group 3: Background on CS-AKI and LSALT Peptide - CS-AKI is a common complication following cardiac surgery, with up to 30% of patients undergoing on-pump surgery developing this condition, which can lead to serious complications and increased mortality [14]. - LSALT peptide is designed to prevent inflammation-related kidney injury by inhibiting the dipeptidase-1 (DPEP1) enzyme, which is primarily expressed in the kidney [10]. - There are currently no approved pharmacologic therapies for preventing CS-AKI, highlighting a significant unmet medical need in this area [16]. Group 4: Additional Clinical Trials - The company is also conducting the PONTiAK Phase II trial to evaluate cilastatin for preventing AKI associated with nephrotoxic pharmaceuticals, with a target enrollment of 698 patients across five sites in Alberta [12]. - No adverse events related to cilastatin have been reported in the PONTiAK trial, and recruitment is ongoing [13]. Group 5: Company Overview - Arch Biopartners Inc. is focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD), with a pipeline that includes LSALT peptide and cilastatin [17][18]. - The company aims to address significant unmet needs in kidney care through its innovative therapeutic approaches [17].