TORONTO, November 5, 2025 — Arch Biopartners Inc. (TSXV: ARCH, OTCQB: ACHFF) announced that the Fraser Health Research Ethics Board (REB) has approved the inclusion of Royal Columbian Hospital (RCH) in New Westminster, British Columbia, as a new site in its ongoing Phase II clinical trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery–associated acute kidney injury (CS-AKI). With this addition, RCH becomes the eighth global site and the fourth Canadian location participating in the trial. The move underscores Arch’s commitment to expanding its clinical footprint and advancing therapies that target inflammation- and toxin-induced kidney injury, one of the most pressing complications in cardiac surgery patients.
Science Significance
The inclusion of RCH strengthens the scientific integrity and reach of the Phase II LSALT peptide program, which targets the dipeptidase-1 (DPEP-1) enzyme, a key mediator of inflammation and organ injury following cardiac surgery. By blocking this enzyme, LSALT peptide aims to reduce postoperative kidney injury, a common and serious complication impacting up to 30% of cardiac surgery patients. The multicenter design of this study ensures a robust, diverse patient dataset, enhancing the scientific credibility of trial outcomes and supporting the company’s broader mechanism-based approach to kidney protection. Together with ongoing trials of cilastatin and CKD-targeting therapeutics, Arch’s research program reflects a comprehensive scientific strategy addressing both acute and chronic renal injury.
Regulatory Significance
The REB’s approval for RCH marks a critical regulatory milestone in Arch’s cGxP-aligned clinical development program. The site will now proceed with operational approvals, training, and initiation before patient enrollment begins. The Canadian ethics clearance follows similar regulatory endorsements across North America and positions Arch favorably for eventual Health Canada and U.S. FDA discussions regarding late-phase trial design. Concurrently, Clinical Trials Ontario (CTO) is reviewing Unity Health’s St. Michael’s Hospital for activation, reinforcing the company’s strong compliance and governance framework. Each approval demonstrates Arch’s adherence to Good Clinical Practice (GCP) and commitment to regulatory transparency.
Business Significance
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On the business front, the trial expansion coincides with TSX Venture Exchange approval of Arch’s acquisition of Lipidro Therapeutics Inc., adding a chronic kidney disease (CKD) platform targeting IL-32 to its portfolio. The acquisition strengthens Arch’s pipeline diversity and potential revenue streams, particularly in inflammation-driven renal diseases. Additionally, Arch’s granting of 750,000 stock options to directors and officers, exercisable at $1.70 per share, signals long-term confidence in corporate performance and investor alignment. These developments underscore the company’s financial discipline and pipeline expansion strategy, reinforcing its market position as a high-value innovator in kidney therapeutics.
Patients’ Significance
For patients undergoing cardiac surgery, acute kidney injury (AKI) remains a life-threatening postoperative risk. The LSALT peptide trial represents a potential breakthrough in perioperative care, offering the prospect of reducing AKI incidence and improving recovery outcomes. With hundreds of millions globally affected by kidney injury or disease, Arch’s multi-targeted approach offers new hope for prevention, faster recovery, and reduced dependence on dialysis. Expanding trial access through Canadian and U.S. sites ensures greater patient diversity and contributes to developing globally applicable kidney-protection therapies.
Policy Significance
Arch Biopartners’ progress reflects the growing alignment between Canadian research institutions, ethics boards, and global regulatory agencies to accelerate the development of innovative kidney therapies. The REB approval exemplifies how local governance and global scientific collaboration can streamline multi-site clinical research, reinforcing Canada’s role as a leader in ethical, regulated biomedical innovation. Moreover, Arch’s adherence to clinical trial transparency, cGxP standards, and sustainable research ethics contributes to advancing policy objectives that prioritize patient safety and innovation-driven healthcare delivery.
The expansion of Arch Biopartners’ Phase II CS-AKI trial to include Royal Columbian Hospital marks another step in the company’s mission to develop novel, mechanism-driven therapies for kidney disease. Supported by regulatory rigor, scientific innovation, and strategic growth, Arch is building a comprehensive platform targeting acute and chronic renal injury through biologically validated pathways. As the global trial network expands, Arch Biopartners continues to demonstrate how science, compliance, and patient-centered vision can converge to advance the next generation of renal care solutions.
Source: Arch Biopartners press release
