Arch Biopartners Inc. announced that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee 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. The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January.

Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February. 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 IRI to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program(NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial. 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.

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, Ivert et al, 20144, Harky et al, 20205).