Diabetes drug teplizumab fails in tests

The potential diabetes drug teplizumab has been suspended from further tests after the treatment failed to reach the main efficacy goal in a late-stage study. The investigational type 1 diabetes biologic drug, which was being developed under licence by Eli Lilly and MacroGenics Inc., has been suspended from further any enrolment and dosing in two ongoing clinical trials .
Teplizumab was undergoing tests for treating newly diagnosed type 1 diabetes, and was being developed to slow down the progression of the condition.
MacroGenics have said that a data monitoring committee (DMC) completed their planned examination of one-year safety and efficacy data of a Phase III trial of teplizumab, and found that the primary efficacy endpoint, a composite of a patient’s total daily insulin usage and HbA1c level after 12 months, had not been satisfied. The DMC said that appropriate safety monitoring was justified, although no unanticipated safety issues were identified in the review.
Gwen Krivi, head of product development at Lilly Diabetes, said that 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.”
The suspension follows the news that the Food and Drug Administration (FDA) in the US has postponed approval on Eli Lilly’s drug Bydureo, a long-acting version of diabetes drug Byetta, as it wanted further testing and data analysis done. The treatment was being developed with Amylin and Alkermes, and was expected to gain approval from the agency.