Tolerx, GSK Diabetes Study Misses Endpoint


Tolerx and GlaxoSmithKline’s Phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint in patients with new-onset autoimmune type 1 diabetes.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Tolerx and GlaxoSmithKline’s Phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint in patients with new-onset autoimmune type 1 diabetes. Preliminary data did not show new or unexpected treatment-related safety concerns during the study. GSK will continue to explore additional dosing regimens in the clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongo...

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