The University of Calgary’s Conjoint Health Research Ethics Board (CHREB) has given the green light for Arch Biopartners Inc. to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). This approval enables the clinical team at the University of Calgary Cumming School of Medicine to collaborate with Arch Biopartners in preparing for patient recruitment in Calgary, pending final approval from Alberta Health Services.
Simultaneously, patient recruitment continues at five clinical sites in Turkey, where the trial has been underway since March. Enhancements to the study protocol have been implemented to improve trial execution, with these changes approved by Health Canada and awaiting approval from the Turkish Ministry of Health.
Richard Muruve, CEO of Arch Biopartners, expressed satisfaction with the progress, highlighting the significance of starting patient dosing in Canada, which is expected to significantly boost the trial.
The CS-AKI Phase II trial is an international, multicenter, randomized, double-blind, placebo-controlled study aiming to recruit 240 patients. Its primary objective is to assess the percentage of subjects experiencing acute kidney injury within seven days following on-pump cardiac surgery, based on the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
CS-AKI is a common complication post-cardiac surgery, with a prevalence of up to 30%, and is associated with increased morbidity and mortality. The condition is often caused by ischemia-reperfusion injury (IRI), leading to kidney cell damage. Currently, there is no therapeutic treatment available to prevent AKI in on-pump cardiac surgery patients.
LSALT peptide, Arch Biopartners' lead drug candidate, targets the dipeptidase-1 (DPEP1) pathway and has shown promise in preventing IRI to the kidneys in pre-clinical models. The scientific rationale for using LSALT peptide in this trial is supported by findings published in Science Advances, detailing its potential to govern renal inflammation during ischemia reperfusion injury.
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury, developing new drugs to target inflammation in the kidneys, liver, and lungs via the DPEP1 pathway.
