Transition Therapeutics has announced that a clinical study of gastrin analogue TT-223, in combination with Eli Lilly’s proprietary GLP-1 analogue, in patients with type 2 diabetes did not meet its efficacy endpoints. Given these findings, the companies decided to end any further development of TT-223.
"Development of a disease modifying therapy for type 2 diabetes is a high-risk endeavor, but one that is needed by the millions of people living with this disease," said Tony Cruz, MD, chairman and CEO of the Toronto-based Transition. “While TT-223 has shown efficacy through development, these results indicate that it does not have the product profile for a diabetes therapy.”
The study was a randomized, double-blind, placebo-controlled study in approximately 150 patients to evaluate the safety, tolerability and efficacy of daily TT-223 treatments, in combination with weekly administrations of the GLP-1 analogue, for a combination treatment period of four weeks with a five-month follow-up, Transition reported.
Transition added the next-generation diabetes compounds it has in-licensed from Lilly, as announced in March, act through a different mechanism of action from gastrin-based therapies. The companies said they will continue to work on this program and the licensing arrangement is unaffected by the TT-223 clinical study results.