Arch Biopartners  has announced that St Michael’s Hospital, part of Unity Health Toronto, has commenced patient dosing in its ongoing Phase II clinical trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

St. Michael’s Hospital becomes the third Canadian site actively recruiting patients in the study, alongside Toronto General Hospital, part of University Health Network, and the University of Calgary Cumming School of Medicine. Preparatory activities are also underway at Royal Columbian Hospital, which is expected to begin recruitment soon.

The company reported that blinded data review confirms consistent detection of acute kidney injury (AKI) using predefined study criteria, supporting the robustness of the trial design and endpoints. To date, investigators have not attributed any adverse events or serious adverse events to LSALT peptide, and no suspected unexpected serious adverse reactions (SUSARs) have been reported.

Arch is also progressing discussions to expand the trial into additional sites in Canada and the United States, aiming to accelerate patient enrolment and enhance clinical awareness among cardiac and renal specialists. Several potential sites are currently under evaluation, with agreements pending.

The international, multicentre, randomised, double-blind, placebo-controlled Phase II study is targeting 240 patients undergoing on-pump cardiac surgery. Participants receive either LSALT peptide or placebo, with the primary endpoint measuring the incidence of AKI within seven days post-surgery, based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

CS-AKI is a common and serious complication of cardiac surgery, often caused by ischemia-reperfusion injury, which damages kidney tissue and can lead to organ failure. Currently, there are no approved drug therapies for preventing this condition.

LSALT peptide, Arch’s lead drug candidate, targets the dipeptidase-1 (DPEP1) enzyme to reduce inflammation-related organ injury. Preclinical and early clinical findings have demonstrated its potential to reduce inflammation and improve outcomes in kidney and lung conditions.

In parallel, the company is supporting the investigator-led PONTiAK Phase II trial evaluating cilastatin for preventing AKI caused by nephrotoxic drugs. The study is ongoing in Alberta, with plans to expand into the US. No treatment-related adverse events have been reported in this trial so far.

Acute kidney injury remains a significant unmet medical need, affecting up to 30 percent of cardiac surgery patients and a substantial proportion of individuals exposed to certain medications. Arch’s integrated pipeline, including LSALT peptide and cilastatin, aims to address inflammation- and toxin-related kidney injury and improve patient outcomes.