Diabetes drug otelixizumab fails in late trials

The diabetes drug otelixizumab failed its phase III trials, it has emerged. The type 1 diabetes investigational drug, a humanised anti-CD3 monoclonal antibody, and developed by GlaxoSmithKline (GSK) and US biotech firm Tolerx, failed in a late-stage clinical trial.
The companies announced that the drug did not meet the primary efficacy endpoint of change in C-peptide, a measurement of how well insulin -producing beta cells are functioning in the pancreas . The failure during the phase III DEFEND-1 study of otelixizumab, which involved 272 patients, occurred at the 12th month in patients with new-onset autoimmune type 1 diabetes.
The problem has also led GSK to halt new recruitment and dosing in the DEFEND-2 study, a confirmatory Phase III study with a similar design to DEFEND-1, while the results of the latter are assessed.
Jackie Parki, medicines development leader at GSK, commented “Clearly these are disappointing data, but we are committed to working with Tolerx to better understand the results of this study and determine the way forward.”
The London-based company that licensed the drug, BTG, pointed out that the findings from the DEFEND-1 study are “obviously disappointing, though we note that GSK is continuing development of otelixizumab in autoimmune diseases “.