TORONTO, Canada, August 11, 2026
Arch Biopartners Inc. announced plans to expand its ongoing Phase 2 clinical trial of LSALT peptide for the prevention of cardiac surgery-associated acute kidney injury (CS-AKI) into the United States. The expansion follows interest from clinicians at five leading U.S. institutions and builds on recruitment progress at four Canadian clinical sites and five sites in Turkey that initially recruited patients. The company reported that patient recruitment has maintained momentum, with no study-drug-related adverse events reported and AKI occurring consistently among enrolled patients. Arch said these factors support expansion of the randomized trial to additional U.S. centers to increase access to eligible patients and support continued recruitment.
U.S. Expansion Targets Cardiac Surgery-Associated AKI
CS-AKI is a common complication following on-pump cardiac surgery, in which a heart-lung machine is used during the procedure. The condition can contribute to longer hospital stays and poorer clinical outcomes. Arch’s Phase 2 study is evaluating whether LSALT peptide can reduce the incidence of AKI following cardiac surgery. The company expects U.S. sites to require approximately four to six months for site preparation, contracting, regulatory review, training and other start-up activities before dosing their first patients. The actual timeline will vary by institution and remains dependent on completion of applicable regulatory and operational requirements.
Phase 2 Trial Designed to Evaluate AKI Prevention
The CS-AKI study is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial with a recruitment target of 240 patients. The primary endpoint is the percentage of patients developing acute kidney injury within seven days following on-pump cardiac surgery, using the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. The trial is already being conducted at Canadian sites, while additional Canadian expansion is also underway. Arch expects the U.S. arm to broaden the clinical network and increase exposure to the LSALT peptide program among kidney specialists, pharmaceutical companies and potential development partners.
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LSALT Peptide Leads Arch’s Acute Kidney Injury Program
LSALT peptide is the lead clinical-stage asset in Arch Biopartners’ kidney disease pipeline and is being evaluated as a potential treatment to protect patients from acute kidney injury associated with cardiac surgery. The company is also developing cilastatin in a separate Phase 2 study targeting toxin-induced AKI and maintains a development platform focused on chronic kidney disease. Arch’s broader strategy is to develop mechanism-based therapies addressing different causes of kidney damage across both acute and chronic kidney disease. The CS-AKI Phase 2 expansion into the United States represents an important development milestone, but clinical efficacy has not yet been established, and the ultimate benefit of LSALT peptide will depend on results from the ongoing trial.
Source:Arch Biopartners press release
