Arch Biopartners Inc. (Arch or the company) announced that Dalton Pharma Services (Dalton) has completed the good manufacturing practice (GMP) glass vial filling stage for cilastatin, the company?s second drug candidate for preventing acute kidney injury (AKI). Over the next six to eight weeks Dalton will be completing the quality control process which will culminate with the release of a first-ever, stand-alone cilastatin drug product to be used in a Phase II trial targeting drug toxin related AKI in hospitalized patients. Arch has agreed to be an industry partner with a group of Canadian clinical researchers in a planned Phase II clinical trial targeting drug toxin-related AKI, which is expected to start in late 2024.

The company will be acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice. Arch has method of use patents in several jurisdictions including North America and Europe for repurposing cilastatin as a treatment for AKI. The patents are proprietary and/or exclusively licensed to Arch.

This announcement marks the completion of an important milestone in the company?s plans to repurpose cilastatin as a new treatment to prevent toxin related AKI.