Arch Biopartners Announces First Patient Successfully Dosed at Toronto General Hospital in Phase II Trial of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury

• First patient successfully completes dosing at Toronto General Hospital
• St. Michael’s Hospital is expected to be the next Canadian clinical site activated
• Arch is looking for additional clinical sites in North America to join the trial

TORONTO, Aug. 06, 2025 (GLOBE NEWSWIRE) --  (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the , 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).

Toronto General Hospital, ranked as the #3 hospital in the world and Canada’s top-ranked hospital by , is the first clinical site in Ontario to dose a patient in this trial. 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 recruitment in Turkey is being limited to diversify the demographic and geographic patient data produced by the trial.

Quote from Richard Muruve, CEO, Arch Biopartners:

“The start of dosing at Toronto General Hospital marks an important milestone in advancing Arch’s Phase II CS-AKI trial. The goal is to recruit about half of the trial’s patients in North America. 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.”

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.

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 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.

Details of the Phase II trial, titled “” can be viewed at .

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.

is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. It targets the dipeptidase-1 (DPEP1) enzyme, which is primarily expressed in the kidney, to inhibit its role in driving inflammation. Arch scientists and their collaborators have demonstrated that LSALT prevents . This mechanism was first described in the journal and further characterized in , by Lau et al. in a paper titled “”.

Findings from an earlier Phase II trial evaluating LSALT peptide for acute lung inflammation were published in . 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 continued clinical development for preventing inflammation injury in the kidneys, lungs and liver. Additional pathway are available on the .

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 this high-risk population.

About Arch Biopartners

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury and organ damage caused by inflammation. The Company is developing a platform of novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway prevalent in the kidneys, lungs, and liver.

LSALT peptide and cilastatin are lead drug candidates in separate Phase II trials targeting acute kidney injury caused by inflammation and toxins, respectively. Both indications represent significant unmet medical needs in global kidney care.

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The Company has 65,906,366 common shares outstanding.

For more information, please contact:

Aaron Benson

Director of Communications

Arch Biopartners, Inc.

647-428-7031

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Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in our 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, our 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. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at .

References:

1. Nadim, M., et al. “Cardiac and Vascular Surgery–Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group”, Journal of the American Heart Association, 2018, 7(11). /10.1161/JAHA.118.008834
   
   
   
   
2. Scurt, F. G., et al. “Cardiac Surgery–Associated Acute Kidney Injury”, Kidney360 5(6):p 909-926, June 2024. /10.34067/KID.0000000000000466
   
   
   
   
3. Vervoort, D., et al. “Global Cardiac Surgical Volume and Gaps: Trends, Targets, and Way Forward.” Annals of Thoracic Surgery Short Reports, 2024, 2:320–324. /10.1016/j.atssr.2023.11.019

The scientific and medical content of this release has been approved by the Company’s Chief Science Officer

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