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. 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. 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. Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI): Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality.