Arch Biopartners Announces Health Canada No Objection Letter (NOL) Granted for Investigator-Led Phase II PONTiAK Trial Using Cilastatin to Target Drug-Toxin-Related Acute Kidney Injury (AKI)

Core Points - Arch Biopartners Inc. has received a No Objection Letter from Health Canada to proceed with the Phase II trial titled "Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin" (PONTiAK) [1][6] - The PONTiAK trial will involve 700 patients and aims to evaluate the efficacy of cilastatin in preventing acute kidney injury (AKI) caused by various drugs [2] - The clinical team has secured funding of $1,500,000 from the Canadian Institutes of Health Research and an additional$400,000 from the Accelerating Clinical Trials initiative [3] Company Overview - Arch Biopartners is focused on developing novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway, with a particular emphasis on preventing acute kidney injury and organ damage [11] - The company is developing two lead drug candidates: LSALT peptide and cilastatin, both aimed at addressing significant unmet medical needs related to kidney injury [11] Trial Details - The PONTiAK trial will be conducted at up to five hospital sites in Alberta, with the next steps including site preparation and obtaining necessary approvals from local ethics boards [4][5] - Arch Biopartners is acting as a study partner, providing cilastatin drug product and exploring opportunities to sponsor a new arm of the study in other jurisdictions [5] Background on AKI and Cilastatin - Acute kidney injury (AKI) can result from various causes, including drug toxins, which account for approximately 30% of AKI cases in hospitalized patients [7] - Cilastatin was originally developed to limit the breakdown of imipenem and is currently being repurposed by Arch Biopartners to target AKI [8][9]