One-year trial data showed teplizumab therapy did not reduce insulin need.
MacroGenics and Eli Lilly are evaluating future prospects for their humanized anti-CD3 monoclonal antibody teplizumab, after a pivotal clinical trial in patients with recent-onset type 1 diabetes failed to meet its primary endpoint. The firms have confirmed that an evaluation of one-year data from the Phase III Protege trial by the study’s Data Monitoring Committee found teplizumab therapy had no benefits in terms of a patient’s total daily insulin usage and HbA1c levels.
MacroGenics and Lilly are now suspending further enrollment and dosing of patients in a second Phase III trial, Protege Encore, and a Phase Ib study that is evaluating subcutaneous administration of teplizumab in patients with type 1 diabetes.
The firms admit the DMC’s findings are disappointing. “Lilly and MacroGenics will be considering all options for teplizumab in type 1 diabetes as well as the impact of the DMC’s recommendations on other potential indications,” notes Gwen Krivi, vp product development at Lilly’s diabetes division.
Lilly teamed up with MacroGenics in 2007 to develop the latter’s teplizumab and other potential next-generation anti-CD3 molecules for treating autoimmune diseases. At the time MacroGenics earned $44 million in an up-front payment and committed funding. Lilly received exclusive rights to teplizumab.