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.

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 ongoing confirmatory Phase III study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.

“While we are disappointed in the DEFEND-1 results of otelixizumab, we remain committed to the development and commercialization of the candidates in our pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses,” said Douglas J. Ringler, VMD, president and chief executive officer of Tolerx. “Our immunotherapy candidates represent some of the latest scientific advances in harnessing the immune system for therapeutic benefit, including TRX518 which is a showpiece of our pipeline as an immunotherapy to treat cancer.”