Tolerx and its partner GSK experienced the agony of defeat when their drug otelixizumab, an anti-CD3 mAb, failed to meet its endpoints in its latest phase III study. Recruiting for subsequent studies have ben suspended while the data is examined.
The anti-CD3 molecule represented a new approach to try to treat type 1 diabetes by blocking the immune system from attacking insulin producing cells in the pancreas. After an 8-day course of treatment, the expression of C-peptide (insulin production) was supposed to increase. It didn't happen.
In 2007, GSK paid Tolerx $70 million upfront, $155 M to support advanced R&D, and could have paid another $350 million in milestones and another $175 million in specific sales milestones. The whole deal had the potential to be worth $760 million. BTG, a London-based drug developer and orginal licensor of the drug, also was hit negatively by the news.
Now it is back to the drawing board on this diabetes application - and application that Lilly also failed with late last year with its similar drug teplizumab. Tolerx vows it will stick with other candidates in its pipeline aimed at treating abnormal immune responses. BTG said it would also pursue other autoimmune applications of otelixizumab.
Posted by Bruce Lehr March 12th 2011.