University of Calgary Approves Phase II Trial for LSALT Peptide in CS-AKI

TORONTO, June 18, 2024-- Arch Biopartners Inc. ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced the approval of a Phase II trial for LSALT peptide by the University of Calgary’s Conjoint Health Research Ethics Board (CHREB). This trial aims to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).

The University of Calgary Cumming School of Medicine's clinical team is collaborating with Arch to finalize preparation and training, ensuring the commencement of patient recruitment in Calgary. Meanwhile, they anticipate final approval from Alberta Health Services. 

Patient recruitment is already underway at five clinical sites in Turkey. Since the trial began dosing patients in March, there have been modifications to the study protocol to enhance the trial's execution. These changes have been approved by Health Canada and are awaiting approval from the Turkish Ministry of Health.

Richard Muruve, CEO of Arch Biopartners, expressed his satisfaction with the ethics approval from CHREB and the progress in patient recruitment in Turkey. He looked forward to beginning recruitment in Calgary and subsequently in Toronto, which he believes will significantly boost the trial.

The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study involving 240 patients. Its primary goal is to assess the percentage of subjects with acute kidney injury (AKI) within seven days post-on-pump cardiac surgery, following the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Detailed information about the trial can be found on clinicaltrials.gov.

CS-AKI is a common complication following coronary artery bypass grafting (CABG) and other cardiac surgeries, especially those involving on-pump procedures, which heighten the risk of AKI. CS-AKI often results from ischemia-reperfusion injury (IRI), where reduced blood flow and oxygen to the kidney cause cell damage. Upon restoration of blood flow, inflammation worsens kidney cell injury. Currently, no therapeutic treatment exists to prevent this type of acute kidney injury, which in severe cases can lead to kidney failure requiring dialysis or transplantation.

LSALT peptide is Arch Biopartners' leading drug candidate for preventing and treating inflammation injury in the kidneys, lungs, and liver. It targets the dipeptidase-1 (DPEP1) pathway and has demonstrated, in pre-clinical models, its effectiveness in preventing IRI in the kidneys. These findings, which form the scientific basis for using LSALT peptide in the CS-AKI trial, were published in the journal Science Advances.

Acute kidney injury occurs in up to 30% of patients post-cardiac surgery and is associated with increased morbidity and mortality. The CS-AKI Phase II trial addresses a significant unmet medical need by potentially offering a preventive treatment for this complication.

Arch Biopartners Inc. is a clinical-stage company focused on preventing inflammation and acute organ injury. They are developing a drug platform targeting the DPEP1 pathway to address inflammation in the kidneys, liver, and lungs, which is relevant for a variety of common injuries and diseases where organ inflammation is a critical issue.

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