Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

TORONTO, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee 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.

The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January. Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February.

Quote from Richard Muruve, CEO of Arch Biopartners Inc:

“We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial. At the same time, we continue to progress on a day-to-day basis to prepare Canadian sites for the trial while waiting for a response from Health Canada on our recent Clinical Trial Application.”

Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide

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.

LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown to prevent 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.