Arch Biopartners Inc. has announced the commencement of patient recruitment and dosing in Canada for its Phase II clinical trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The first patient was dosed at the University of Calgary Cumming School of Medicine.
Trial Details and Objectives
The Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy of LSALT peptide. The trial aims to recruit 240 patients undergoing on-pump cardiac surgery. The primary objective is to determine the percentage of subjects who develop acute kidney injury (AKI) within seven days following surgery, based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Additional clinical sites at the University Health Network and Unity Health Toronto are in the final stages of approval to begin patient recruitment.
LSALT Peptide and Mechanism of Action
LSALT peptide is Arch Biopartners' lead drug candidate, targeting the dipeptidase-1 (DPEP1) pathway to prevent and treat inflammation-related injuries in the kidneys, lungs, and liver. CS-AKI often results from ischemia-reperfusion injury (IRI), where restricted blood flow during surgery leads to kidney cell damage, followed by inflammation upon blood flow restoration. Currently, there are no approved therapeutic treatments specifically designed to prevent AKI in on-pump cardiac surgery patients. Pre-clinical studies have demonstrated LSALT peptide's ability to prevent IRI in the kidneys, providing a rationale for its use in this trial. These findings were published in Science Advances by Lau et al., highlighting DPEP1's role in renal inflammation during ischemia-reperfusion injury.
The Burden of CS-AKI
Acute kidney injury (AKI) is a frequent complication in patients undergoing coronary artery bypass grafting (CABG) and other on-pump cardiac surgeries. Studies report the prevalence of CS-AKI to be as high as 30%, which is independently associated with increased morbidity and mortality rates. Effective prevention and treatment strategies are needed to improve outcomes in this patient population.
Management Commentary
Richard Muruve, CEO of Arch Biopartners, stated, "We are happy to see the team at the University of Calgary Hospital recruit and dose the first patient in Canada for our Phase II study targeting CS-AKI... The start of recruitment in Calgary, followed by the activation into the study of the two Toronto hospitals, will significantly boost the momentum of the trial."
