Mr. Richard Muruve reports

UNIVERSITY OF CALGARY JOINS THE PHASE II TRIAL OF LSALT PEPTIDE TARGETING CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY

A research team from the University of Calgary's Cumming School of Medicine has joined Arch Biopartners Inc.'s 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.

"We know that acute kidney injury impairs recovery and can negatively affect long-term outcomes following heart surgery. Our research team is excited to participate in a study working towards improving kidney health in our patients," said Alex Gregory MD, assistant professor and director of research, division of cardiovascular anesthesia at the Libin Cardiovascular Institute at the Cumming School of Medicine, and site principal investigator for the LSALT phase II CS-AKI trial.

Dr. Gregory's clinical team has submitted an application to the local research ethics board for permission to participate in the trial.

The addition of the first Canadian clinical site increases the number of trial sites to four, with three hospitals in Turkey currently recruiting patients. There are three additional hospital sites in Turkey pending activation into the trial. The Arch Biopartners team is currently working with two other hospital sites in Canada to prepare for their participation in this phase II trial.

The CS-AKI phase II trial is an international multicentre, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (kidney disease: improving global outcomes) criteria.

Details of the phase II trial, entitled "Phase 2 Global, Multicentre, 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," can be viewed on-line.

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. There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in preclinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury," by Lau et. al. and can be found along with previous peer-reviewed publications about DPEP-1 and LSALT peptide at the company's website.

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.

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 per cent and is independently associated with an increase in morbidity and mortality.

About Arch Biopartners Inc.

Arch Biopartners is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The company is developing new drug candidates that inhibit inflammation in the lungs, kidneys and liver through the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

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