Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Rhea-AI Summary

Arch Biopartners Inc. (TSX Venture: ARCH and OTCQB: ACHFF) has submitted a Clinical Trial Application to Health Canada for a Phase II trial of LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI). The trial plans to recruit up to 240 patients in Canada, Turkey, and the United States, with patient recruitment expected to begin in early 2024.

TORONTO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

This application, and one recently submitted in Turkey, follows the Company’s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration’s (FDA). The FDA granted the Company permission to proceed with a Phase II trial in late June.

The Phase II CS-AKI trial plans to recruit up to 240 patients and will be a double-blinded, placebo-controlled study conducted in hospital sites in Canada, Turkey and the United States.

Patient recruitment is expected to begin in Turkey in early 2024, upon approval from the local ethics committee. Patient recruitment will follow in Canada after regulatory approvals and the onboarding of the first Canadian clinical site. Sites in the U.S. may be added in future.

Once sites are active in the trial, patient recruitment will be done on a competitive basis between sites, until the planned total number of patients are recruited into the study. This study is designed to produce a signal of safety and efficacy that would support a larger Phase III trial, and eventually the approval of LSALT peptide as a new pharmaceutical product.

Quote from Richard Muruve, CEO of Arch Biopartners Inc:

“The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our Phase II trial targeting CS-AKI. The Arch team and our Canadian collaborators look forward to working together to test LSALT peptide against the risks of AKI during by-pass cardiac surgery, which is a large unmet medical problem.”

Cardiac Surgery-Associated AKI and LSALT peptide

Cardiac surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. In the worst cases of AKI, kidneys fail leading to kidney dialysis or kidney transplant.

LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Details of the Phase II trial, entitled “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.

The Science Advances publication, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. can be found at the journal’s website.

Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial.

Incidence of Cardiac Surgery-Associated AKI

Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of cardiac surgery-associated acute kidney injury (CS-AKI) is up to 30% and is independently associated with an increase in morbidity and mortality.

Cardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. Approximately 0.6% to 5% of patients undergoing cardiac surgery will require immediate postoperative dialysis or renal replacement therapy, and these patients have a very high early mortality rate up to 25% compared with 1% to 2% in patients who do not require immediate postoperative dialysis (Conlon et al, 1999¹, Chertow et al, 2005², Zakeri et al, 2005³, Ivert et al, 2014⁴, Harky et al, 2020⁵).

About Arch Biopartners

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

For more information on Arch Biopartners' science and technologies, 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 62,755,633 common shares outstanding.

References:

^1. Conlon PJ, Stafford-Smith M, White WD, et al. Acute renal failure following cardiac surgery. Nephrol Dial Transplant. 1999;14:1158–62

^2. Chertow GM, Burdick E, Hoinour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16:3365-70

^3. Zakeri R, Freemantle N, Barnett V, et al. Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting. Circulation. 2005;112(suppl):I270–5

^4. Ivert T, Holzmann MJ, Sartipy U. Survival in patients with acute kidney injury requiring dialysis after coronary artery bypass grafting. Eur J Cardiothoracic Surg. 2014;45:312–7

^5. Harky A, Joshi M, Gupta S, et al. Acute kidney injury associated with cardiac surgery: a comprehensive literature review. Braz. J. Cardiovasc. Surg. 2020;35(2).

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), 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.sedar.com .

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

FAQ

What is the company name and ticker symbol for the Clinical Trial Application submitted to Health Canada?

Arch Biopartners Inc. (TSX Venture: ARCH and OTCQB: ACHFF)

What is the purpose of the Phase II trial for LSALT peptide?

The trial aims to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).

How many patients is the Phase II trial planning to recruit?

The trial plans to recruit up to 240 patients.

When is patient recruitment expected to begin for the Phase II trial?

Patient recruitment is expected to begin in early 2024.

Where will patient recruitment take place for the Phase II trial?

Patient recruitment is expected to take place in Canada, Turkey, and the United States.

What is the expected outcome of the Phase II trial for LSALT peptide?

The trial is designed to produce a signal of safety and efficacy that would support a larger Phase III trial and eventually the approval of LSALT peptide as a new pharmaceutical product.