Mr. Richard Muruve reports

ARCH BIOPARTNERS ADDS THREE NEW CLINICAL SITES INTO THE PHASE II TRIAL FOR LSALT PEPTIDE TARGETING CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY

Arch Biopartners Inc. has added three additional clinical sites in Turkey to the phase 2 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.

The three new hospitals joining the phase 2 study are Istanbul University-Cerrahpasa, Sutcu Imam University Hospital in the city of Kahramanmaras and the Gazi University Hospital in Ankara, the capital of Turkey. The trial now has a total of seven clinical sites across Turkey and Canada.

About the phase 2 trial for LSALT peptide targeting CS-AKI

Arch Biopartners is currently sponsoring a phase 2 trial for LSALT peptide targeting cardiac-surgery-associated acute kidney injury.

CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen 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. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI.

The CS-AKI phase 2 trial is an international, multicentre, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (kidney disease: improving global outcomes) criteria.

LSALT peptide has been shown by Arch scientists and their collaborators to prevent ischemia-reperfusion injury to the kidneys in preclinical models. Details of their findings were published in a Science Advances publication, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury," by Lau et al., and can be found at the Science Advances website.

Details of the phase 2 trial, entitled "Phase 2 global, multicentre, 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 the Clinical Trials government website.

About LSALT peptide

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 preclinical studies. 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.

See the 2019 Cell publication, titled "Dipeptidase-1 is an adhesion receptor for neutrophil recruitment in lungs and liver," by Choudhry et al., available at the Cell website.

Arch Biopartners' clinical team published a peer reviewed publication in the British Medical Journal Open (BMJ Open -- March, 2024, volume 14, issue 3) detailing the clinical and biomarker results of the international phase 2 human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virus. See the full publication at the BMJ Open 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 via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

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