Arch Biopartners Announces Ethics Approval for St. Michael's Hospital to Participate in the Phase II Cardiac Surgery-Associated AKI Trial for LSALT Peptide

Executive Summary

• The University Health Network Research Ethics Board approved St. Michael’s Hospital (Unity Health Toronto) to join Arch Biopartners’ Phase II LSALT peptide trial for cardiac surgery‑associated acute kidney injury (CS‑AKI).
• This marks the ninth global site and fourth within Unity Health Toronto, expanding the trial’s enrollment capacity toward its 240‑patient target.
• Additional sites in Canada and the United States are being evaluated, with other Canadian hospitals already enrolling patients.

Key Details

• Ethics Approval: Granted by UHN REB via Clinical Trials Ontario (CTO) Stream system for St. Michael’s Hospital, Toronto, Ontario.
• Site Status: Will complete operational approvals, training, and site initiation before patient enrollment begins.
• Trial Scope: International, multi‑center, randomized, double‑blind, placebo‑controlled Phase II study of LSALT peptide (10 mg IV twice daily for five days) versus placebo in patients undergoing on‑pump cardiac surgery.
• Recruitment Target: 240 patients across all sites.
• Current Sites:
• Active enrollment – University Health Network’s Toronto General Hospital (Ontario) and University of Calgary Cumming School of Medicine (Alberta).
• Recent REB approval – Royal Columbian Hospital (British Columbia), preparing for site initiation.
• Global Expansion: St. Michael’s becomes the ninth global site; Arch continues to evaluate additional Canadian and U.S. sites.
• Primary Endpoint: Percentage of subjects developing AKI within seven days post‑surgery, defined by KDIGO criteria.
• Background on LSALT Peptide: First‑in‑class DPEP1 inhibitor targeting inflammation‑mediated organ injury; prior Phase II lung study showed biomarker reductions (e.g., CXCL10).

Notable Quotes

“Our research team is excited to be participating in this trial. Organ injury and repair is a Unity Health Toronto Research Pillar, and we are committed to investigating key mechanisms underlying tissue injury and healing, and to developing therapies to reduce injury and enhance regeneration.” – Dr. David Mazer, Translational researcher, anesthesiologist & intensivist, St. Michael’s Hospital.