Eli Lilly has suffered another clinical setback after its investigational type I diabetes biologic teplizumab failed in a late-stage study.
Lilly and partner MacroGenics noted that a data monitoring committee has completed a planned analysis of one-year safety and efficacy data of a Phase III trial of teplizumab and concluded that the primary efficacy endpoint, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. The DMC commented that appropriate safety monitoring is warranted while "no unanticipated safety issues were identified" in the review.
The companies have now decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes. Gwen Krivi, head of product development at Lilly Diabetes, noted that the failure to meet the primary endpoint "is obviously disappointing" and the partners "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".
News of the failure came a day after the US Food and Drug Administration said Bydureon (extended-release exenatide) a long-acting version of the diabetes drug Byetta being developed with Amylin and Alkermes, is not approvable at the moment and requested more data.