Arch Biopartners wins IRB approval to open U.S. sites in CS-AKI trial

Arch Biopartners has received central Institutional Review Board approval for its Phase II trial of LSALT peptide in cardiac surgery-associated acute kidney injury, clearing a key procedural hurdle as the Toronto-listed company moves to open clinical sites in the United States for the first time.

The central IRB review covers the trial protocol and related study documents, and allows prospective U.S. institutions to rely on the ethical review rather than conducting parallel local board assessments. The company said this mechanism is intended to accelerate site activation at the five U.S. institutions that have expressed interest in joining the study.

Expanding a multi-centre programme

The Phase II CS-AKI study is a randomised, double-blind, placebo-controlled trial with a target recruitment of 240 patients. It is evaluating whether LSALT peptide reduces the incidence of acute kidney injury within seven days of on-pump cardiac surgery, using the KDIGO (Kidney Disease: Improving Global Outcomes) criteria as the definitional standard. Existing sites are located in Canada, with past participation from sites in Turkey.

Arch said U.S. sites typically require four to six months to complete contracting, training, regulatory review, and other start-up activities before the first patient can be dosed. Some preparatory work with prospective institutions is already under way. The timeline will vary by site, and is conditional on all applicable approvals being obtained.

Richard Muruve, chief executive of Arch Biopartners, said the U.S. expansion was both a clinical development priority and a strategic step toward building a broader international profile. "For Arch, it is also a strategic step toward establishing a stronger global presence as we advance our clinical-stage kidney programs," he said.

An additional Canadian site is also moving through the activation process in parallel, indicating the company is pursuing growth on both fronts simultaneously.

Market context and competitive landscape

CS-AKI is a well-recognised and clinically significant complication of cardiac surgery, associated with prolonged hospitalisation and elevated mortality risk. Despite its prevalence, there are currently no approved pharmacological interventions specifically indicated for its prevention, leaving the field reliant on perioperative fluid management and haemodynamic support.

The kidney protection space has attracted increasing attention from larger players. AstraZeneca's dapagliflozin demonstrated renal protective effects in chronic kidney disease and heart failure settings, and several academic groups are investigating anti-inflammatory peptide approaches in acute kidney injury. Arch's positioning of LSALT peptide around the dipeptidase-1 (DPEP1) pathway represents a mechanistically distinct approach from SGLT2 inhibition, though head-to-head comparisons with any approved agent are not yet possible at this stage.

With a 240-patient recruitment target spread across multiple countries and a primary endpoint read-out at the seven-day post-surgical window, the trial is relatively lean for a Phase II study. Investors will be watching enrolment velocity as the key near-term variable: U.S. site activation would materially increase monthly recruitment capacity and could pull forward any interim or topline data readout. Arch also has a second Phase II programme underway evaluating cilastatin, a repurposed agent, in toxin-induced AKI, giving the company parallel clinical activity across the acute renal injury space.