ARCH Arch Biopartners Inc

Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the University Health Network Research Ethics Board, through the Clinical Trials Ontario Streamlined Research Ethics Review System, has granted provincial ethics approval for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

The clinical teams at Toronto General Hospital and St. Michael’s Hospital in Toronto are now seeking final internal approvals and completing final preparations to begin patient recruitment in the first quarter of 2025.

The trial continues to recruit patients at the University of Calgary Hospital and five clinical sites in Turkey.

Quote from Richard Muruve, CEO, Arch Biopartners

“Our thanks to the University Health Network team for smoothly navigating the Ontario ethics board approval process over the last 12 months. This milestone is an important step forward for our Phase II CS-AKI trial, as preparations continue at our two Toronto clinical sites to begin enrolling patients.”

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.

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 on clinicaltrials.gov.

CS-AKI and LSALT peptide

Cardiac surgery-associated acute kidney injury (CS-AKI) is often caused by ischemia-reperfusion injury (IRI), which reduces blood flow (ischemia) and oxygen to the kidneys, causing kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidneys. Currently, no therapeutic treatment is available to prevent acute kidney injury (AKI) of the type commonly experienced by on-pump cardiac surgery patients. In severe cases of AKI, kidney failure occurs, requiring kidney dialysis or kidney transplant for survival.

LSALT peptide is Arch’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in the current CS-AKI trial. Details of their findings were published in the journal Science Advances, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et al. and can be found, along with the latest peer-reviewed publications about DPEP1 and LSALT peptide on the Company’s website.

Incidence of CS-AKI

CS-AKI is a common complication in patients following coronary artery bypass grafting (CABG) and other cardiac surgeries, particularly on-pump procedures, which significantly elevate the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with increased morbidity and mortality.

Other Corporate Developments

The Company has entered into a one-year marketing and consulting contract (the "Contract") with Toronto-based marketing firm, Outside The Box Capital Inc. (“OTB”), which specializes in various social media platforms and will work to facilitate greater awareness and widespread dissemination of the Company's news.

In connection with the Contract, the Company will pay OTB $25,000 per month during the Contract period and grant 150,000 two-year stock options with a strike price at $2.00 per share, effective January 7, 2025. Outside The Box Capital Inc. currently owns 0 shares of the Company.

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.

Its lead drug candidates, LSALT peptide and cilastatin, are being developed to target kidney injury caused by inflammation or toxins respectively, which are both significant unmet medical needs.

For more information on Arch Biopartners’ science and drug platform, please visit: www.archbiopartners.com/our-science

For investor information and other public documents the company has also filed on SEDAR+, please visit www.archbiopartners.com/investor-hub

The Company has 64,858,352 common shares outstanding.

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 www.sedarplus.ca.

The science and medical contents of this release have been approved by the Company’s Chief Science Officer

Neither 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

For more information, please contact:

Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.
647-428-7031
info@archbiopartners.com