GSK, Tolerx's late-stage trial for otelixizumab doesn't meet endpoints

CAMBRIDGE, Mass. — A late-stage trial of a biologic treatment for Type 1 diabetes appears to have failed, according to results announced Friday.

GlaxoSmithKline and Tolerx said results of the 272-patient, phase-3 “DEFEND-1” study of otelixizumab indicated it did not preserve the function of insulin-producing cells in the pancreas, as measured by levels of the protein C-peptide, which is used to measure the amount of insulin the body is producing. Patients received a single, eight-day intravenous course of the drug no more than 90 days after diagnosis. Pending review of the results of DEFEND-1, patient recruitment for a second study, “DEFEND-2,” has been suspended, the companies said.

“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,” Tolerx president and CEO Douglas Ringler said.

Type 1 diabetes, formerly called juvenile-onset diabetes, is an autoimmune disorder in which the immune system destroys the pancreatic cells that produce insulin.

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