Arch Biopartners Receives Permission From U.S. FDA to Proceed With Phase II Acute Kidney Injury Trial

  • Approval from FDA to initiate Phase II trial with LSALT peptide to target cardiac surgery-associated acute kidney injury (CS-AKI)
  • LSALT peptide targets dipeptidase-1 (DPEP-1), an enzyme known to mediate organ inflammation in the lungs, liver and kidneys
  • There are currently no treatments available to prevent or treat AKI

TORONTO, June 27, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) for a Phase II human trial for LSALT peptide targeting 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 lungs, liver and kidneys.

This decision follows the FDA’s review of the Company’s investigational new drug (IND) application submitted to the FDA’s Division of Cardiology and Nephrology on May 26, 2023. The IND application included preclinical data, Phase I and Phase II clinical data to date, manufacturing processes, and the protocol design for the CS-AKI Phase II trial.

The CS-AKI trial has 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. Patient recruitment is expected to begin in the fall of 2023, pending approvals from local health authorities, ethics committees and internal review boards. 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.

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 using LSALT peptide in this CS-AKI trial.

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.

Recent funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly help cover the costs of this Phase II trial.

Quote from Richard Muruve, CEO of Arch Biopartners Inc:

“The FDA’s decision to grant a Study May Proceed letter is the culmination of 18 months of work by the Arch team to scale up LSALT manufacturing, perform dose escalation studies for LSALT peptide and complete significant planning and preparation for the CS-AKI trial. We look forward to taking LSALT peptide to trial patients who are at risk to CS-AKI, as there are currently no treatments available to prevent or treat AKI.”

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.

LSALT Peptide Drug Product Manufacturing Update

During the last year, Arch advanced the production of a new supply of LSALT peptide to be used in new human trials. The production of approximately 10,000 LSALT peptide drug product vials were recently completed and have been released for human use to support human trials. The new vials completed quality control and quality assurance procedures at the Company’s third-party manufacturing facility and have been moved to storage, pending delivery to clinical sites.

About 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 RRT, 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 (Chertow et al, 19981, Conlon et al, 19992, Zakeri et al, 20053, Ivert et al, 20144, Harky et al, 20205).

About LSALT Peptide and Dipeptidase-1 (DPEP-1) Mediated Organ Inflammation

LSALT peptide is a novel peptide drug candidate and DPEP-1 inhibitor. In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified, for the first time, as a major leukocyte (white blood cell) adhesion receptor on the lung, liver and kidney endothelium. DPEP-1 was also identified as the target of LSALT peptide, differing from typical anti-inflammatory drugs by targeting this novel adhesion receptor rather than targeting individual cytokines, of which there are many.

The Cell publication, titled “Dipeptidase-1 is an adhesion receptor for neutrophil recruitment in lungs and liver” by Choudhry et. al. can be found at the journal’s website.

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 multiple medical indications 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 62,398,825 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 patientsJ 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


For more information, please contact:

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

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