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Study of otelixizumab in type 1 diabetes did not meet primary endpoint
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The phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at 12 months in patients with new-onset type 1 diabetes, according to an announcement from Tolerx and GlaxoSmithKline.
Preliminary review revealed no new or unexpected treatment-related safety concerns during DEFEND-1, according to a press release.
The randomized, placebo-controlled, phase 3 DEFEND-1 study enrolled 272 patients aged 12 to 45 years with new-onset type 1 diabetes. It was conducted at more than 100 centers in North America and Europe. The study was designed to evaluate whether a single 8-day IV course of otelixizumab 3.1 mg administered up to 90 days after the initial diagnosis of type 1 diabetes preserved the insulin-producing beta cell function in the pancreas, as measured by C-peptide. The primary endpoint was measurement of C-peptide at 12 months.
Tolerx and GlaxoSmithKline will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory phase 3 study with a design similar to DEFEND-1, has been suspending pending review of the DEFEND-1 results.
“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,” Jackie Parkin, medicines development leader at GlaxoSmithKline, said in a press release.
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