TORONTO, Canada, August 31, 2026

Arch Biopartners Inc. announced that it has received central Institutional Review Board (IRB) approval for the protocol and related study documents supporting the U.S. expansion of its ongoing Phase II clinical trial of LSALT peptide in cardiac surgery-associated acute kidney injury (CS-AKI). The approval represents an important clinical development milestone because it enables prospective U.S. clinical sites to use the central IRB review rather than completing separate local institutional reviews, potentially helping streamline the site activation process. Arch previously announced plans to expand the CS-AKI study into the United States following interest from clinicians at five leading institutions. The U.S. expansion is intended to broaden patient recruitment and increase the international reach of the LSALT peptide development program. Existing trial activities continue at clinical sites in Canada, while an additional Canadian site is also progressing through activation.

Central IRB Approval Advances U.S. Trial Activation

The central IRB approval provides an important regulatory and operational foundation for activating the planned U.S. clinical sites participating in the LSALT peptide study. Arch Biopartners said prospective sites will still need to complete institution-specific requirements, including site preparation, contracting, regulatory review, investigator and staff training, and other start-up activities before enrolling patients. The company currently expects newly added U.S. sites to require approximately four to six months to complete these activities and dose their first patients, although timelines may vary by institution. Some of the required start-up activities are already underway at prospective sites. The U.S. expansion therefore moves the CS-AKI program beyond its existing Canadian footprint and represents a significant step toward establishing a broader North American clinical development network for LSALT peptide.

Phase II Study Targets Cardiac Surgery-Associated AKI

The Phase II CS-AKI trial is evaluating whether LSALT peptide can reduce the incidence of acute kidney injury following on-pump cardiac surgery, where the use of a heart-lung machine can contribute to postoperative kidney complications. The study is designed as a multi-center, randomized, double-blind, placebo-controlled Phase II trial with a planned recruitment target of 240 patients. Its primary objective is to determine the percentage of participants who develop acute kidney injury within seven days following on-pump cardiac surgery, using the established KDIGO criteria. Cardiac surgery-associated AKI can contribute to longer hospital stays and poorer clinical outcomes, creating a significant need for effective approaches that can protect kidney function in high-risk surgical patients. Expansion into U.S. centers is expected to broaden the study’s recruitment potential while generating additional clinical experience with LSALT peptide in this patient population.

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Arch Expands Clinical Development Footprint

The U.S. expansion builds on progress already achieved at Canadian clinical sites and previous clinical activity in Turkey, while adding new institutions to the ongoing CS-AKI development program. For Arch Biopartners, the central IRB milestone strengthens the operational foundation needed to bring U.S. sites into the Phase II study and potentially increase enrollment opportunities for the program. The company is focused on developing therapies for acute kidney injury (AKI) and chronic kidney disease (CKD), with LSALT peptide representing its lead clinical-stage program targeting CS-AKI. Arch is also advancing a separate Phase II program evaluating cilastatin for toxin-induced AKI, but the company’s immediate development activity highlighted in this announcement centers on the U.S. expansion of the LSALT peptide trial. With central ethical review now completed, the next major steps for the U.S. arm will be site activation, completion of start-up requirements and initiation of patient dosing. The company expects the expansion to strengthen the global clinical development pathway for LSALT peptide as it advances through Phase II evaluation..

Source:Arch Biopartners, press relese