Health Canada Approves Phase II Trial of LSALT Peptide for Post-Cardiac Surgery AKI

Arch Biopartners Inc., a clinical-stage company, has received approval from Health Canada to initiate a Phase II study for their leading drug candidate, LSALT peptide. This trial aims to prevent and treat acute kidney injury (AKI) associated with cardiac surgery. The LSALT peptide is designed to mitigate inflammation and injury in vital organs such as the kidneys, lungs, and liver.

The study is structured as an international, multi-center, randomized, double-blind, and placebo-controlled research endeavor. It will focus on measuring the incidence of AKI within seven days post-cardiac surgery, using the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO). Currently, no market-available treatments specifically target the prevention of AKI in cardiac surgery patients.

The Health Canada's No Objection Letter is in addition to previous approvals from the U.S. Food and Drug Administration and the Turkish Ministry of Health, paving the way for the Phase II trial. Patient recruitment is slated to begin in Turkey in February 2024, with further expansion to clinical sites in Alberta and Ontario, Canada.

CS-AKI is typically triggered by ischemia-reperfusion injury (IRI), which involves a reduction in blood flow to the kidneys, leading to cell damage. The subsequent restoration of blood flow can exacerbate the injury through inflammation. In severe cases, this can result in kidney failure, necessitating dialysis or transplant. There are no existing treatments for CS-AKI or IRI.

The LSALT peptide works by targeting the dipeptidase-1 (DPEP-1) pathway, which has demonstrated the ability to prevent inflammation and IRI in pre-clinical studies. This provides a scientific basis for its use in the CS-AKI trial.

The National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) has offered advisory services and financial support, which will help to reduce the costs associated with the Phase II trial. AKI is a frequent complication following coronary artery bypass grafting (CABG) and other cardiac surgeries, with a reported prevalence of up to 30%, and is linked to increased morbidity and mortality.

Arch Biopartners is dedicated to the development of new drug candidates that inhibit inflammation in organs affected by common injuries and diseases where organ inflammation poses an unmet challenge.