TORONTO, Dec. 16, 2025 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the University Health Network Research Ethics Board (“UHN REB”) has granted ethics approval for St. Michael's Hospital, a site of Unity Health Toronto, to participate in Arch's ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With the UHN REB approval, issued through the Clinical Trials Ontario (CTO) Stream system, St. Michael's Hospital in Toronto, Ontario will now proceed to complete operational approvals, training, and site initiation before commencing patient enrollment. St. Michael's Hospital will be the ninth site activated globally and the fourth site within one of 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. The University Health Network's Toronto General Hospital (Ontario) and the University of Calgary Cumming School of Medicine (Alberta) continue to actively enroll new patients in the trial. At Royal Columbian Hospital (British Columbia), the study team has recently received REB approval and is preparing for site initiation. Arch also continues to evaluate additional sites in Canada and the United States to join the CS-AKI Phase II trial. About the CS-AKI Phase II Trial 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. 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 of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Details of the Phase II trial, titled “Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery“ can be viewed at ClinicalTrials.gov. CS-AKI and LSALT peptide CS-AKI often results from ischemia-reperfusion injury (IRI), which restricts blood flow and oxygen to the kidney (ischemia), leading to kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidney. There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. In the worst cases of AKI, the kidneys fail, requiring dialysis or a kidney transplant for survival. LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. It binds to the dipeptidase-1 (DPEP1) 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 IRI to the kidneys in pre-clinical models (video). 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 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 as a therapeutic target for organ inflammation. 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 LSALT's proposed mechanism of action and its continued development for preventing inflammation injury in critical organs. 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.1–3 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 patients at high risk of developing AKI. About Unity Health Toronto Unity Health Toronto is Canada's largest Catholic health care provider with a wingspan across Toronto's core. The breadth of services we provide, strengthened by community partnerships and academic affiliations, positions us as a national model for collaborative, integrated, high quality care as we work to build a stronger, resilient and equitable health system for all. Unity Health Toronto's strength lies in the combined expertise of our sites. St. Joseph's Health Centre is a community academic and acute care hospital supporting Toronto's west end. St. Michael's Hospital is a research-intensive academic health sciences centre offering world-class specialty programs for complex cases. Providence Healthcare is a campus of care for seniors, rehabilitation and long-term care. We also have a constellation of satellite clinics offering team-based primary care and community-based services. Our Mission and Values are the foundation of all that we do, and have been our guide since our founding by the Sisters of St. Joseph of Toronto more than 150 years ago. We aim to provide compassionate, high quality care at every stage of our patients' health journey, from pediatric to primary care, urgent and acute care, world-class specialty care programs, seniors care, rehabilitation, long-term care, palliative care and advanced care for the most complex patients. As a leading Canadian health research institution and learning destination of choice for health professionals, we are advancing healthcare for all united by one vision: The best care experiences, created together. About Arch Biopartners Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury. Arch's development pipeline includes: 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. For more details about the Company's science and ongoing clinical trials, please visit: www.archbiopartners.com/our-science Follow Arch on LinkedIn, Bluesky, and X (formerly Twitter) for scientific insights and industry news. The Company has 66,933,289 common shares outstanding. For more information, please contact: Aaron Benson Send a message or subscribe for email alerts at: www.archbiopartners.com/contact-us Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of the Company's future performance, liquidity, and capital resources, as well as the ongoing development of its drug candidates targeting chronic kidney disease and the dipeptidase-1 (DPEP-1) pathway, including the outcome of its clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of its drug candidates, whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe, and other countries, its ability to raise capital to fund its business plans, the efficacy of its drug candidates compared to the drug candidates developed by competitors, its ability to retain and attract key management personnel, and the breadth of, and its ability to protect, its intellectual property portfolio. These statements are based on management's current expectations and beliefs, including certain factors and assumptions, as described in the Company's most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, the actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company undertakes no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including the Company's most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca. References: The scientific and medical content of this release has been reviewed and approved by the Company's Chief Science Officer. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Director of Communications
Arch Biopartners Inc.
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