GSK & Tolerx suffer Phase III otelixizumab setback
This article was originally published in Scrip
Executive Summary
Targeting CD3 to treat type 1 diabetes has once again been called into question as GSK and Tolerx revealed that the Phase III DEFEND-1 study of otelixzimuab did not meet its primary endpoint in patients with new-onset autoimmune type 1 diabetes. The partners have suspended new recruitment and dosing in the DEFEND-2 study pending review of the DEFEND-1 results. Last autumn, MacroGenics and partner Eli Lilly announced that their anti-CD3 mAb failed to show efficacy in a pivotal Phase II/III trial in type 1 diabetes patients missing the same primary endpoint.