Arch Biopartners Inc. has announced a significant advancement in its development of cilastatin, a drug candidate designed to prevent acute kidney injury (AKI) caused by drug toxins. Dalton Pharma Services has completed the good manufacturing practice (GMP) glass vial filling stage for cilastatin, marking the preparation of the first standalone cilastatin drug product. Over the next six to eight weeks, Dalton will finalize the quality control process, leading to the release of the product for a Phase II clinical trial scheduled to begin in late 2024.

Arch is collaborating with Canadian clinical researchers for this Phase II trial, focusing on drug toxin-related AKI in hospitalized patients. The company will provide cilastatin drug product, act as a study partner for grant funding, and offer scientific and regulatory guidance. Arch holds method of use patents for repurposing cilastatin to treat AKI in several jurisdictions, including North America and Europe.

Originally developed by Merck Sharp & Dohme Research Laboratories, cilastatin inhibits enzymatic dipeptidase-1 (DPEP1) to prevent the renal metabolism of imipenem, an antibiotic. Unlike Arch's LSALT peptide, which blocks DPEP1-mediated inflammation in specific organs, cilastatin's broader mechanism includes preventing toxin uptake in the kidneys, making it suitable for toxin-related AKI.

AKI encompasses various causes from mild to severe renal injury, including drug toxins. Currently, no specific therapeutic treatment exists to prevent AKI, which in severe cases may necessitate kidney dialysis or transplant. Cilastatin shows promise in preventing AKI induced by nephrotoxic drugs, addressing a significant need in clinical settings.

 

Source: globenewswire.com

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