Mr. Richard Muruve reports

ARCH BIOPARTNERS RECEIVES APPROVAL FROM ETHICS COMMITTEE IN TURKEY TO PROCEED WITH PHASE II CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY TRIAL FOR LSALT PEPTIDE

Arch Biopartners Inc. has 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 enrolment can begin in February.

Quote from Richard Muruve, chief executive officer of Arch Biopartners:

"We look forward to a positive decision from the MoH, which will permit enrolment of Turkish cardiac surgery patients into the trial. At the same time, we continue to progress on a day-to-day basis to prepare Canadian sites for the trial while waiting for a response from Health Canada on our recent clinical trial application."

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. 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 preclinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Details of the phase II 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 on-line.

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 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.

Cardiopulmonary bypass (CPB) surgery occurs in nearly one million patients per year. Approximately 0.6 per cent to 5 per cent 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 per cent compared with 1 per cent to 2 per cent in patients who do not require immediate postoperative dialysis (Conlon et al., 1999, Chertow et al., 2005, Zakeri et al., 2005, Ivert et al., 2014, Harky et al., 2020).

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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