Arch Biopartners Announces St. Michael's Hospital Commences Patient Dosing in the Phase II CS-AKI Trial of LSALT Peptide
Executive Summary
- St. Michael’s Hospital began dosing patients in Arch Biopartners’ Phase II CS‑AKI trial of LSALT peptide, marking the third Canadian site to recruit.
- No adverse events or SUSARs have been reported to date; blinded data continue to show AKI occurrences consistent with protocol criteria, supporting study design.
- Arch is expanding recruitment to additional Canadian sites and evaluating three U.S. sites (plus one Ontario site) for the CS‑AKI trial, while also advancing the PONTiAK Phase II cilastatin trial in Alberta and planning a U.S. arm.
Key Details
- Trial Sites:
- Canada – St. Michael’s Hospital (Toronto), Toronto General Hospital, University of Calgary Cumming School of Medicine, Royal Columbian Hospital (site start‑up).
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Prospective expansion – three U.S. cardiac surgery centres and one additional Ontario site under consideration.
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LSALT Peptide Dosing Regimen: 10 mg IV twice daily for five days.
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CS‑AKI Phase II Trial Design: International, multicenter, randomized, double‑blind, placebo‑controlled; target enrollment = 240 patients; primary endpoint = % of subjects with AKI within 7 days post on‑pump cardiac surgery (KDIGO criteria).
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Safety Update:
- No adverse events or serious adverse events deemed related to LSALT peptide.
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No SUSARs reported.
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Data Review: Blinded interim review shows AKI incidence aligns with protocol expectations, confirming study design and endpoint suitability.
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Regulatory/Compliance: Annual safety reports submitted to Turkish Ministry of Health; final close‑out visits being prepared for first five Turkish sites.
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PONTiAK Phase II Trial (Cilastatin):
- Objective – prevent AKI from nephrotoxic drugs.
- Current recruitment in Calgary and Edmonton hospitals; total planned enrollment = 698 patients across five Alberta sites.
- No drug‑related adverse events reported to date.
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Planning a U.S. arm to broaden exposure.
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Future Site Development: Ongoing feasibility discussions, site evaluations, investigator commitments, budget development, and clinical trial agreement drafting for additional Canadian and U.S. locations.
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Company Context: LSALT peptide targets DPEP1‑mediated inflammation; preclinical efficacy published in Cell (2019) and Science Advances (2022). Earlier Phase II lung‑inflammation data published in BMJ Open (2024) showing biomarker reductions (e.g., CXCL10).
Notable Quotes
“The initiation of patient dosing at St. Michael’s Hospital underscores the steady progress of our CS‑AKI trial and reinforces confidence in LSALT peptide’s safety profile as we move toward broader enrollment across North America.” – Aaron Benson, Director of Communications, Arch Biopartners Inc.