Tolerx and GlaxoSmithKline (GSK) have announced that the phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.
“Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study,” the companies said. “Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.”
The London-based GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory phase III study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.
"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," said Jackie Parkin, medicines development leader at GlaxoSmithKline.