Teplizumab, also called MGA031 and hOKT31 (Ala-Ala), is a humanized, anti-CD3 monoclonal antibody. It is an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.
The DMC, composed of independent experts in the fields of diabetes and biostatistics, stated that appropriate safety monitoring is warranted and that no unanticipated safety issues were identified in the review.
MacroGenics president and CEO Scott Koenig said that they would comply with the DMC’s recommendations.
Based on the result, MacroGenics and Lilly have decided to suspend further recruitment and dosing of patients in two other ongoing clinical trials of Teplizumab in type 1 diabetes, that is, the Protege Encore Trial, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.
Lilly Diabetes Product Development vice president Gwen Krivi said that the failure to meet the primary endpoint is obviously 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," Krivi said.
MacroGenics is a private, venture-backed biotechnology company that focuses on the discovery, development and delivery to patients of novel biologics for autoimmune disorders, cancer and infectious diseases.