Arch Biopartners Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide
TORONTO, Sept. 22, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced that it has submitted applications to the Ministry of Health (MoH) and local Ethics Committee in Turkey 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 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 subsequently granted the Company permission to proceed with this Phase II trial in late June.
The CS-AKI trial plans to recruit up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the U.S., Turkey, and Canada. Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.
Following approvals from the MoH and the Ethics Committee, patient recruitment is expected to begin as planned in the fall (fourth quarter) of 2023. The trial will begin with patient recruitment at clinical sites in Turkey, followed by eventual on boarding of clinical sites in the U.S. and Canada.
There will be an independent Data Safety Monitoring Board which will monitor the safety of the patients enrolled in the trial. This study is designed to produce a signal of efficacy that would justify a larger Phase III trial.
Quote from Richard Muruve, CEO of Arch Biopartners Inc:
“We are very happy to be returning to Turkey to begin a Phase II human trial targeting CS-AKI, which is a large unmet medical problem. The Arch team and our colleagues in Turkey have been working hard the last couple of months to prepare the regulatory submissions, select clinical sites and mobilize to execute the trial. As a result, Arch is on schedule to dose the first patient in the fourth quarter of 2023.”
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 62,598,815 common shares outstanding.
For more information, please contact:
Chief Executive Officer
Arch Biopartners, Inc.
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).
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
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