Arch Biopartners Inc. announced that it has received a No Objection Letter from Health Canada to conduct 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. The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

The primary objective of the trial is to evaluate the percentage of subjects with AKI within 7 days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. There is no treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. The No Objection Letter from Health Canada follows prior approvals from the U.S. Food and Drug Administration and the Turkish Ministry of Health to proceed with the Phase II CS-AKI trial in their respective jurisdictions.

Patient enrollment is expected to commence in Turkey in February 2024, followed by recruitment in Canada at select clinical sites in Alberta and/or Ontario. Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide: CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated.

In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown to prevent inflammation and IRI to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.