Mr. Richard Muruve reports

ARCH BIOPARTNERS SUBMITS APPLICATION TO HEALTH CANADA TO CONDUCT THE PHASE II CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY TRIAL FOR LSALT PEPTIDE

Arch Biopartners Inc. has submitted a clinical trial application to Health Canada to obtain permission 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.

This application, and one recently submitted in Turkey, follows the company's submission of an investigational new drug application to the U.S. Food and Drug Administration (FDA). The FDA granted the company permission to proceed with a phase II trial in late June.

The phase II CS-AKI trial plans to recruit up to 240 patients and will be a double-blinded, placebo-controlled study conducted in hospital sites in Canada, Turkey and the United States.

Patient recruitment is expected to begin in Turkey in early 2024, upon approval from the local ethics committee. Patient recruitment will follow in Canada after regulatory approvals and the onboarding of the first Canadian clinical site. Sites in the U.S. may be added in future. Once sites are active in the trial, patient recruitment will be done on a competitive basis between sites, until the planned total number of patients are recruited into the study. This study is designed to produce a signal of safety and efficacy that would support a larger phase III trial, and eventually the approval of LSALT peptide as a new pharmaceutical product.

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

"The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our phase II trial targeting CS-AKI. The Arch team and our Canadian collaborators look forward to working together to test LSALT peptide against the risks of AKI during bypass cardiac surgery, which is a large unmet medical problem."

Cardiac surgery-associated AKI and LSALT peptide

Cardiac surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) 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. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. In the worst cases of AKI, kidneys fail leading to kidney dialysis or kidney transplant.

LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in preclinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

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 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 cardiac surgery-associated acute kidney injury (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., 20144, 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.

We seek Safe Harbor.