Arch Biopartners to Expand Phase II Cardiac Surgery-Associated Acute Kidney Injury Trial to the United States

TORONTO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (TSX Venture: ARCH and OTCQB: ACHFF) today announced that the Company will expand its ongoing Phase II trial of LSALT peptide targeting cardiac surgery-associated acute kidney injury (“CS-AKI”) into the United States, following interest from clinicians at five leading U.S. institutions.

The planned U.S. expansion builds on progress at the four Canadian clinical sites currently participating in the trial and patient data collected from the five sites in Turkey that were the first to recruit patients to the study. Patient recruitment has maintained momentum; there have been no adverse events related to the study drug, and AKI has occurred consistently among enrolled patients, validating trial design. These factors support the Company’s decision to expand the study with additional sites.

Expanding the trial to the U.S. is intended to increase access to eligible patients and support continued recruitment. The Company is also continuing to grow the trial in Canada as one additional Canadian site moves through the activation process.

“We are seeing strong interest from American clinicians to join our CS-AKI trial for LSALT peptide to protect patients from cardiac surgery-related acute kidney injury. Establishing a U.S. arm of the study will increase awareness of LSALT peptide and our Phase II trial among kidney care specialists, the pharmaceutical industry and potential partners,” said Richard Muruve, Chief Executive Officer of Arch Biopartners.

The Company expects new U.S. clinical sites to require approximately four to six months to complete site preparation, contracting, regulatory review, training and other start-up activities before dosing their first patients. Timing will vary by institution and is subject to the completion of all applicable approvals.

The Company will provide further updates as U.S. clinical sites complete the steps required to join and begin recruiting patients in the trial.

About the CS-AKI Phase II Trial

Cardiac surgery-associated acute kidney injury is a common complication following on-pump (heart-lung machine) cardiac surgery and can lead to longer hospital stays and worse outcomes. The trial is designed to evaluate whether LSALT peptide can reduce the rate of AKI in this setting.

The CS-AKI Phase II trial is a multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

Details of the Phase II trial can be viewed at ClinicalTrials.gov: NCT05879432.

About Arch Biopartners

Arch Biopartners Inc. is a therapeutic biotechnology company developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury.

Arch’s development pipeline includes:

• LSALT peptide: in a Phase II trial targeting cardiac surgery-associated AKI.
• Cilastatin: a repurposed drug in a Phase II trial targeting toxin-induced AKI.
• CKD Platform: next-generation therapeutics targeting chronic kidney disease.
  

These assets represent distinct, mechanism-based approaches focused on protecting the kidney from different causes of damage. Chronic kidney disease affects more than 800 million people worldwide,¹ while acute kidney injury adds a further significant burden. Together, Arch’s programs target unmet needs across both acute and chronic kidney disease. Both Phase II programs are currently enrolling patients at Canadian clinical sites, with an additional Canadian site in development and a U.S. expansion of the CS-AKI trial underway.

For more details about the Company’s science and ongoing clinical trials, please visit www.archbiopartners.com/our-science

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The Company has 67,933,289 common shares outstanding.

For more information, please contact:

Aaron Benson
Director of Communications
Arch Biopartners Inc.
647-428-7031

Send a message or subscribe for updates 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 (DPEP1) pathway, including the outcomes of its clinical trials relating to LSALT peptide (Metablok) and 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’s discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, 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:

1. Mark, Patrick B., et al. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023. The Lancet, 2025;406(10518), 2461–2482. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01853-7/fulltext
   

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