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.