Tolerx and GlaxoSmithKline announced that its Phase 3 study of otelixizumab for the treatment of new-onset autoimmune type 1 diabetes did not meet its primary efficacy endpoint, change in C-peptide at Month 12. This was a randomized, placebo-controlled trial of 272 patients, age 12–45, with new onset type 1 diabetes. The study was designed to evaluate whether a single 8-day intravenous course of otelixizumab, administered not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes, preserved the function of insulin-producing beta cells in the pancreas, as measured by C-peptide. GlaxoSmithKline will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab.
Otelixizumab is a humanized monoclonal antibody that targets CD3, a T lymphocyte receptor involved in normal cell signaling.