GSK, Tolerx diabetes drug flunks PhIII

GlaxoSmithKline and partner Tolerx were dealt a blow as their drug otelixizumab failed a late-stage trial. The drug, a humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune Type 1 diabetes. Reuters notes the trial failure wasn't entirely unexpected given that a similar drug from Eli Lilly--teplizumab--failed clinical trials last year.

GSK said it will explore additional dosing regimens before it makes a final decision regarding the future of otelixizumab. The companies have halted recruitment and dosing in a second study of the drug pending review of the results.

"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," said Tolerx CEO Douglas Ringler.

GSK first partnered with Tolerx in 2007, when the British drugmaker committed up to $760 million for access to the smaller company's monoclonal antibody. That deal included $70 million in upfront fees, equity and advanced R&D funds, up to $155 million in future development costs, $350 million in scheduled milestones for a successful program and $175 million in sales milestones.

- take a look at the Tolerx release
- here's more from Reuters

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