Arch Biopartners Inc. has announced the start of patient recruitment and dosing in Canada for its Phase II trial of LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). This international, multicenter study aims to address a critical unmet need in patients undergoing cardiac surgery.
Trial Design and Objectives
The CS-AKI Phase II trial is designed as a randomized, double-blind, placebo-controlled study. It plans to enroll 240 patients across multiple centers. The primary objective of the trial is to evaluate the percentage of subjects who develop acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery. The diagnosis of AKI will be based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
LSALT Peptide and DPEP1 Pathway
Arch Biopartners is developing a platform of new drugs focused on preventing inflammation and acute organ injury. Their approach targets the dipeptidase-1 (DPEP1) pathway to prevent inflammation in vital organs such as the kidneys, liver, and lungs. The LSALT peptide represents a potential breakthrough in treating common injuries and diseases where organ inflammation affects millions of patients globally each year.
Clinical Significance 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. Reports indicate that the prevalence of CS-AKI can be as high as 30 percent. This condition is independently associated with increased morbidity and mortality rates, highlighting the urgent need for effective preventive and therapeutic strategies.
