Arch Biopartners has initiated patient recruitment for its Phase II PONTIAK trial in Alberta, Canada. This trial will assess the effectiveness of cilastatin in preventing acute kidney injury (AKI) caused by commonly used medications, such as antibiotics and chemotherapy drugs. The prosecution, led by researchers from the University of Calgary and the University of Alberta, has received $1.5 million in funding from the Canadian Institutes of Health Research (CIHR) and an additional $400,000 from the Accelerating Clinical Trials (ACT) initiative.
This Phase II trial is a critical step towards addressing a significant unmet medical need. AKI, often caused by drug toxicity, lacks a preventative treatment. If cilastatin proves effective, it could significantly improve patient outcomes and reduce the burden of AKI on healthcare systems by preventing this serious complication associated with essential medications. This trial is significant as it explores the potential of repurposing a known drug, offering a faster and potentially more cost-effective path to market.
Arch Biopartners manufactured the cilastatin used in the trial. The company is exploring ways to expand the study to other regions, potentially including the United States, through an application to the U.S. Food and Drug Administration. This trial will enroll approximately 698 patients across five hospital sites and is registered on ClinicalTrials.gov (NCT06886464). Arch Biopartners holds method-of-use patents for cilastatin’s application in AKI.
The commencement of this Phase II trial marks significant progress for Arch Biopartners and the potential of cilastatin as a first-in-class preventative treatment for drug-induced AKI. Positive results from this trial could pave the way for larger-scale clinical studies and ultimately lead to regulatory approval, positioning Arch Biopartners as a leader in AKI prevention and offering a valuable new tool for healthcare providers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
