Diabetes trial disappointment for GSK and Tolerx
pharmafile | March 14, 2011 | News story | Research and Development | DEFEND-1, DEFEND-2, GSK, GlaxoSmithKline, Tolerx, diabetes, otelixizumab, type I diabetes
GSK and Tolerx’s type I diabetes drug otelixizumab has failed to meet its primary endpoint in a late-stage trial.
Anti-CD3 monoclonal antibody otelixizumab missed its phase III primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type I diabetes.
Douglas Ringler, president and chief executive of Tolerx, said: “While we are disappointed in the DEFEND-1 results of otelixizumab, we remain committed to the development and commercialisation of the candidates in our pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses.”
New recruitment and dosing in the another phase III study of otelixizumab, DEFEND-2, has been suspended pending review of the DEFEND-1 results.
The DEFEND-1 trial involved 272 patients aged between 12 and 45 and was designed to evaluate whether a single eight-day intravenous course of otelixizumab, administered not more than 90 days after the initial diagnosis of autoimmune type I diabetes, preserved the function of insulin-producing beta cells in the pancreas, as measured by C-peptide.
The C-peptide is a protein that shows how much insulin the body is producing and is a well established surrogate measure of beta cell function.
In type 1 diabetes, the immune system attacks and destroys the insulin-producing beta cells in the pancreas. As a result of the decrease in natural insulin production, patients must monitor their glucose levels frequently and administer insulin regularly to control their blood glucose levels.
“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, GSK.
GSK and Tolerx collaborated in late 2007 to develop and commercialise otelixizumab for a range of autoimmune and immune-mediated inflammatory diseases, including type I diabetes.
Brett Wells
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