Arch Biopartners is set to expand its Phase II clinical trial of the LSALT peptide, a drug candidate targeting cardiac surgery-associated acute kidney injury (CS-AKI), to clinical sites in the US.
The ongoing multi-centre, randomised, double-blind, placebo-controlled study has a recruitment target of 240 patients.
The expansion follows interest from clinicians at five US institutions looking to participate in the study. This trial is already active at four Canadian sites, with five in Türkiye initially leading patient recruitment.
Patient recruitment has continued at a steady rate, with AKI observed in a consistent manner among those enrolled across existing sites.
No adverse events related to the LSALT peptide have been identified to date. These developments have prompted Arch Biopartners to broaden the scope of the study in order to increase access to eligible patients and maintain recruitment momentum.
An additional Canadian clinical site is also in the process of becoming active, while the planned US sites are expected to require four to six months to complete preparatory steps, including contracting, regulatory review, and staff training.
The anticipated timeframe for starting patient dosing at these new US locations will depend on the completion of institution-specific approvals.
Arch Biopartners plans to provide updates as these steps are finalised.
Arch Biopartners CEO Richard Muruve said: "We are seeing strong interest from American clinicians to join our CS-AKI trial for LSALT peptide to protect patients from cardiac surgery-related acute kidney injury.
"Establishing a US arm of the study will increase awareness of LSALT peptide and our Phase II trial among kidney care specialists, the pharmaceutical industry and potential partners."
The study is assessing the proportion who develop AKI in seven days following on-pump cardiac surgery, as defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
CS-AKI is a common complication of cardiac surgery and can lead to longer hospital stays and worse outcomes.
In July 2025, Arch Biopartners initiated subject recruitment in its Phase II study aimed at assessing cilastatin's efficacy in preventing AKI caused by nephrotoxic pharmaceuticals.
"Arch Biopartners plans US expansion of LSALT peptide trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.