Arch Biopartners Inc. announced that it has submitted applications to the Ministry of Health (MoH) and local Ethics Committee in Turkey to obtain permission 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. This application in Turkey follows the Company?s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration?s (FDA).

The FDA subsequently granted the Company permission to proceed with this Phase II trial in late June. The CS-AKI trial 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. Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.

Following approvals from the MoH and the Ethics Committee, patient recruitment is expected to begin as planned in the fall (fourth quarter) of 2023. The trial will begin with patient recruitment at clinical sites in Turkey, followed by eventual on boarding of clinical sites in the U.S. and Canada. 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.