The trial will assess the efficacy of cilastatin in preventing acute kidney injury resulting from the use of medications. Credit: Robina Weermeijer on Unsplash.

Arch Biopartners has announced that its drug candidate cilastatin will be analysed in the upcoming Phase II PONTIAC clinical trial, which aims to prevent acute kidney injury (AKI) caused by nephrotoxic drugs.

Dubbed ‘Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin’ (PONTIAC), the trial is set to enrol 900 patients.

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It will assess the efficacy of cilastatin, a dipeptidase-1 inhibitor, in preventing AKI resulting from the use of medications like antibiotics, chemotherapeutic agents, and radiographic contrast.

The universities of Calgary and Alberta-based clinical team received $1.5m in funding from the Canadian Institutes of Health Research (CIHR) to execute the study.

Additionally, the clinical team received $400,000 from the Accelerating Clinical Trials (ACT) initiative in October last year.

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The trial’s sponsoring clinical team, located in Calgary, is currently preparing to submit a Clinical Trial Application (CTA) to Health Canada, with the aim to initiate the trial by the fourth quarter of this year.

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Arch Biopartners is collaborating as a study partner, providing the cilastatin drug product and offering scientific and regulatory guidance.

Cilastatin, an enzymatic dipeptidase-1 (DPEP1) inhibitor, was initially approved by the FDA in 1985 for use in combination with imipenem to treat bacterial infections.

Arch Biopartners holds method-of-use patents for repurposing cilastatin as a treatment for AKI in various regions, including North America and Europe.

The PONTIAC trial is based on research demonstrating cilastatin’s ability to inhibit leukocyte recruitment and drug toxin uptake in the kidney in pre-clinical models, thus preventing AKI caused by radiographic contrast.

The company is also currently dosing patients with another drug candidate, LSALT peptide (Metablok) in an ongoing international Phase II study targeting cardiac surgery-associated AKI (CS-AKI).

Arch Biopartners CEO Richard Muruve said: “We are excited to be the industry partner of the PONTIAC trial while we continue to sponsor the Phase II trial for LSALT peptide targeting CS-AKI. The PONTIAC and CS-AKI trials combined are targeting about half of all AKI cases occurring in hospitals today.

“We are very driven to complete these trials and improve global kidney care with the first-ever therapeutics to prevent acute kidney injury.”