Teplizumab misses diabetes endpoint

Eli Lilly and Co. (NYSE:LLY) said an analysis from an independent DMC showed that IV teplizumab missed the composite primary endpoint of total daily insulin usage and HbA1c at 12 months vs. placebo in the Phase II/III Protege trial in 516 patients to treat recent-onset Type I diabetes. Based on the results, Lilly and partner MacroGenics Inc. (Rockville, Md.) suspended further enrollment and dosing in two other ongoing trials of the humanized mAb against CD3 in Type I diabetes -- the Phase III Protege Encore trial and the Phase Ib SUBCUE trial. The companies are evaluating next steps for teplizumab. ...