Phase II Trial Initiates with LSALT Peptide for Post-Cardiac Surgery AKI

Patient enrollment and administration of the LSALT peptide have commenced in Turkey as part of a Phase II study aimed at mitigating and preventing acute kidney injury (AKI) associated with cardiac surgery. This peptide is a frontrunner in the development pipeline of Arch Biopartners Inc., designed to curb inflammation in vital organs such as the kidneys, lungs, and liver.

In Turkey, three medical centers are actively enrolling cardiac surgery patients for this trial. Two of these, Koşuyolu Research Hospital and Kocaeli University Research Hospital, are situated in and around Istanbul, while the third is Erciyes University's Faculty of Medicine Organ Transplant & Dialysis Hospital, located in the heart of Turkey. The trial is set to expand with the activation of three more hospital sites in the country.

The research team at Arch Biopartners is also coordinating with Canadian medical facilities to prepare for their involvement in the Phase II trial. This trial is structured as an international, multi-center study that is randomized, double-blind, and placebo-controlled, with a target of enrolling 240 patients. Its primary aim is to measure the proportion of patients who develop AKI within a week post-cardiac surgery, using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as a benchmark.

The trial's details are listed on clinicaltrials.gov under the title "Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery."

Acute kidney injury (AKI), often a consequence of cardiac surgery, is frequently caused by ischemia-reperfusion injury (IRI), which leads to a reduction in blood flow and oxygen to the kidneys, resulting in cell damage. The restoration of blood flow can trigger inflammation and worsen the injury. In severe cases, this can lead to kidney failure, necessitating dialysis or a transplant. Currently, there is no market-available treatment specifically designed to prevent the type of AKI that occurs in patients undergoing on-pump cardiac surgery.

Arch Biopartners' LSALT peptide is designed to target the dipeptidase-1 (DPEP-1) pathway, which has been shown in pre-clinical studies to prevent IRI in the kidneys. This research was published in Science Advances under the title "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et al.

The National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) has provided advisory services and funding, which will significantly reduce the costs associated with the Phase II trial.

AKI is a prevalent complication following coronary artery bypass grafting (CABG) and other types of cardiac surgery, with reported prevalence as high as 30%. It is linked to increased morbidity and mortality rates.

Arch Biopartners Inc. is a clinical-stage company dedicated to the prevention of inflammation and acute organ injury. The company is developing new drug candidates that target the DPEP-1 pathway to inhibit inflammation in organs affected by common injuries and diseases where organ inflammation is a significant issue.