Arch Biopartners Inc. announced it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. This application, and one recently submitted in Turkey, follows the Company's submission of an Investigational New Drug Application to the U.S. Food and Drug Administration's (FDA).

The FDA granted the Company permission to proceed with a Phase I trial in late June. The Phase II CS-AKI trial plans to recruit up to 240 patients and will be a double-blinded, placebo-controlled study conducted in hospital sites in Canada, Turkey and the United States. Patient recruitment is expected to begin in Turkey in early 2024, upon approval from the local ethics committee.

Sites in the U.S. may be added in future. Once sites are active in the trial, patient recruitment will be done on a competitive basis between sites, until the planned total number of patients are recruited into the study. This study is designed to produce a signal of safety and efficacy that would support a larger Phase III trial, and eventually the approval of LSALT peptide as a new pharmaceutical product.

Cardiac surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney causing kidney cell damage. Cardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. Approximately 0.6% to 5% of patients undergoing cardiac surgery will require immediate postoperative dialysis or renal replacement therapy, and these patients have a very high early mortality rate up to 25% compared with 1% to 2% in patients who do not require immediate postoperative dialysis (Conlon et al, 19991, Chertow et al, 20052, Zakeri et al, 20053, Ivertet al, 20144, Harky et al, 20205).