Mr. Richard Muruve reports

ARCH BIOPARTNERS RECEIVES HEALTH CANADA APPROVAL TO CONDUCT PHASE II TRIAL FOR LSALT PEPTIDE TARGETING CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY

Arch Biopartners Inc. has received a no-objection letter from Health Canada to conduct a phase 2 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 phase 2 trial is an international, multicentre, 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 seven 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 today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

The no-objection letter from Health Canada follows prior approvals from the United States Food and Drug Administration and the Turkish Ministry of Health to proceed with the phase 2 CS-AKI trial in their respective jurisdictions. Patient enrolment is expected to commence in Turkey in February, 2024, followed by recruitment in Canada at select clinical sites in Alberta and/or Ontario.

Cardiac-surgery-associated acute kidney injury 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 preclinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Details of the phase 2 trial, entitled "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," can be viewed at the National Library of Medicine website.

The Science Advances publication, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury," by Lau et al. can be found at the journal'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 2 trial.

Incidence of cardiac-surgery-associated acute kidney injury

Acute kidney injury is a known common complication in patients after coronary artery bypass grafting 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 via the dipeptidase-1 pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

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