Mr. Richard Muruve reports

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

Arch Biopartners Inc. learned today that the anesthesia clinical trials unit (ACTU), an academic research organization in the department of anesthesia and pain management at the University Health Network (UHN), has joined the 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.

"Our team of investigators including Dr. Cusimano and Dr. Djaiani alongside with the ACTU is excited to be participating in this trial that may reduce the high burden of acute kidney injury in patients undergoing cardiac surgery. We aim to submit and obtain all necessary institutional approvals to be able to initiate the study at the Toronto General Hospital," said Dr. Karkouti (director, ACTU).

The UHN clinical team has submitted an application to the local ethics board for permission to participate in the trial.

The addition of UHN as the second Canadian hospital site increases the number of trial sites to eight, with six active clinical sites in Turkey.

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.

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 UHN

UHN is Canada's No. 1 hospital and the world's No. 1 publicly funded hospital. With 10 sites and more than 20,000 members of TeamUHN, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education at UHN and West Park Healthcare Centre. As Canada's top research hospital, the scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care.

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 via 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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