Chronic kidney diseases (CKD)
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Arch Biopartners Announces Ethics Approval for St. Michael's Hospital to Participate in the Phase II Cardiac Surgery-Associated AKI Trial for LSALT Peptide
Globenewswireยท 2025-12-16 12:40
Core Viewpoint - Arch Biopartners Inc. has received ethics approval for St. Michael's Hospital to participate in a Phase II trial evaluating LSALT peptide for preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2]. Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD) [16]. - The company is advancing an integrated program targeting inflammation- and toxin-related kidney injury, with LSALT peptide as its lead drug candidate [16]. Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients [5]. - Patients will be randomized to receive either LSALT peptide (10mg IV twice daily for five days) or placebo, with the primary objective being to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery [5][6]. Research and Development - The trial aims to address a significant unmet medical need, as up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, which can lead to serious complications and increased mortality [11]. - LSALT peptide works by binding to the dipeptidase-1 (DPEP1) enzyme, inhibiting its role in triggering organ inflammation, and has shown promise in pre-clinical models for preventing ischemia-reperfusion injury to the kidneys [8][7]. Collaboration and Site Activation - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network [2]. - Other active sites include Toronto General Hospital and the University of Calgary, with additional sites being evaluated in Canada and the United States [4].