Arch Biopartners Inc. announced that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the University Health Network (UHN), Canada's largest academic health sciences centre and a global leader in cardiac care and research. The volunteer patient completed five days of dosing as part of the Company's ongoing Phase II trial evaluating LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI). TGH joins the University of Calgary Hospital as the second Canadian clinical site to dose patients in this trial.
The Company anticipates St. Michael's Hospital (SMH) in Toronto will be the next Canadian site to activate and enroll patients into the study, pending approvals from Clinical Trials Ontario and SMH's ethics board. The Arch team continues to pursue additional clinical sites in Canada and the United States.
Patient dosing completed in Turkey has provided a strong safety profile for LSALT peptide. This has given clinical trial teams increased confidence as new sites join the trial to test LSALT peptide's ability to protect kidneys from acute inflammation injury. The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients.
The start of the Phase II CS-AKI trial and the ongoing dosing of volunteer patients has been mainly supported through non-dilutive funding grants previously disclosed by the Company. The Company will update the study's listing on ClinicalTrials.gov following today's news regarding recruitment at Toronto General Hospital including a revised estimated trial completion date of August 2026. This update reflects the 12 to 18 months required by Canadian sites to complete preparations and obtain provincial and local ethics approvals prior to enrolling patients.
The publication also reported notable biomarker findings: patients treated with LSALT peptide showed reductions in a range of inflammatory biomarkers, including a statistically significant decrease in CXCL10, a protein linked to inflammation in the lungs and kidneys. These results support continued clinical development for preventing inflammation injury in the kidneys, lungs and liver. Additional peer-reviewed publications related to LSALT peptide and the DPEP1 pathway are available on the Company's website.
Incidence of CS-AKI: Acute kidney injury (AKI) is a frequent complication following cardiac surgery, especially in procedures that use a heart-lung machine. Clinical studies report that up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, a condition that increases the risk of serious complications, longer hospital stays, and increased mortality. With no approved therapies available, CS-AKI remains an area of significant unmet medical need.
LSALT peptide offers a potential first-in-class therapeutic approach to prevent inflammation injury in this high-risk population.
