Arch Biopartners Expands Phase II Trial for LSALT Peptide with St. Michael's Hospital Ethics Approval
核心洞察
Arch Biopartners (搜索) received ethics approval for St. Michael's Hospital (搜索) to join its Phase II trial evaluating LSALT peptide for preventing cardiac surgery-associated acute kidney injury (搜索).
The international trial targets 240 patients and represents a potential first-in-class therapeutic approach for CS-AKI, which affects up to 30% of cardiac surgery patients.
LSALT peptide works by binding to the DPEP1 (搜索) enzyme to inhibit organ inflammation, with previous studies showing statistically significant reductions in inflammatory biomarkers.
Arch Biopartners (搜索) Inc. announced that the University Health Network Research Ethics Board has granted ethics approval for St. Michael's Hospital (搜索) to participate in the company's ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (搜索) (CS-AKI). The approval, issued through the Clinical Trials Ontario Stream system, positions St. Michael's Hospital as the ninth site activated globally and the fourth site within Canada's leading academic hospital networks.
"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," said Dr. David Mazer, translational researcher, anesthesiologist and intensivist at St. Michael's Hospital (搜索).
Trial Design and Objectives
The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients. Subjects are randomized to receive either LSALT peptide (10 mg IV twice daily for five days) or placebo, consistent with previous clinical and dose-escalation trials. The primary objective evaluates the percentage of subjects with acute kidney injury (搜索) within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
The University Health Network's Toronto General Hospital and the University of Calgary Cumming School of Medicine continue to actively enroll new patients in the trial. At Royal Columbian Hospital in British Columbia, the study team has recently received REB approval and is preparing for site initiation.
Addressing Significant Unmet Medical Need
Acute kidney injury (搜索) 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. Currently, no therapeutic treatment is available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.
CS-AKI often results from ischemia-reperfusion injury (搜索), which restricts blood flow and oxygen to the kidney, leading to kidney cell damage. When blood flow is restored, inflammation is triggered, exacerbating injury to the kidney. In the worst cases of AKI, the kidneys fail, requiring dialysis or a kidney transplant for survival.
LSALT Peptide Mechanism and Previous Results
LSALT peptide is Arch's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. It binds to the dipeptidase-1 (搜索) (DPEP1 (搜索)) enzyme, which is primarily expressed in the kidney, to inhibit its role in triggering organ inflammation. Arch scientists and their collaborators have demonstrated that LSALT prevents ischemia-reperfusion injury (搜索) to the kidneys in pre-clinical models.
This mechanism was first described in the journal Cell (2019), and further characterized in Science Advances (2022), by Lau et al. in a paper titled "Dipeptidase-1 (搜索) governs renal inflammation during ischemia reperfusion injury."
Findings from an earlier Phase II trial evaluating LSALT peptide for acute lung inflammation were published in BMJ Open (2024). In that study, patients received a 5 mg daily dose of LSALT peptide. The results provided first in-human evidence validating DPEP1 (搜索) as a therapeutic target for organ inflammation. The publication reported notable biomarker findings: patients treated with LSALT peptide showed reductions in a range of inflammatory biomarkers, including a statistically significant decrease in CXCL10 (搜索), a protein linked to inflammation in the lungs and kidneys.
Company Pipeline and Global Impact
Arch Biopartners (搜索) is developing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury. The company's development pipeline includes LSALT peptide in a Phase II trial targeting cardiac surgery-associated AKI, cilastatin as a repurposed drug in a Phase II trial targeting toxin-induced AKI, and a CKD Platform for next generation therapeutics targeting chronic kidney disease (搜索).
These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Together, they target serious unmet needs in kidney care across both chronic and acute indications, affecting more than 800 million patients worldwide. LSALT peptide offers a potential first-in-class therapeutic approach to prevent inflammation injury in patients at high risk of developing AKI.