Mr. Richard Muruve reports

ARCH BIOPARTNERS RECEIVES PERMISSION FROM U.S. FDA TO PROCEED WITH PHASE II ACUTE KIDNEY INJURY TRIAL

Arch Biopartners Inc. has received a study may proceed letter from the United States Food and Drug Administration (FDA) for a phase 2 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 1 and phase 2 clinical data to date, manufacturing processes, and the protocol design for the CS-AKI phase 2 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 3 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 preclinical 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.

A 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 2 trial.

Quote from Richard Muruve, chief executive officer of Arch Biopartners:

"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 2 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 on-line.

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 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 per cent, and is independently associated with an increase in morbidity and mortality.

Cardiopulmonary bypass (CPB) surgery occurs in nearly one million patients per year. Approximately 0.6 per cent to 5 per cent 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 per cent compared with 1 per cent to 2 per cent in patients who do not require immediate postoperative dialysis (Chertow et al., 1998, Conlon et al., 1999, Zakeri et al., 2005, Ivert et al., 2014, and Harky et al., 2020).

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 Inc.

Arch Biopartners 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 through the dipeptidase-1 (DPEP-1) pathway and are relevant for multiple medical indications where organ inflammation is an unmet problem.

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