Transition halts diabetes drug development

Transition Therapeutics has discontinued development of a potential new therapy for type 2 diabetes after it failed to meet the efficacy endpoints in a late-stage clinical study. The drug, gastrin analogue TT-223, was being tested in combination with a GLP-1 analogue that Transition licensed from Lilly.

"While TT-223 has shown efficacy through development, these results indicate that it does not have the product profile for a diabetes therapy," the company said.

The randomised, double-blind study enroled 150 patients who received either a placebo regimen or daily doses of TT-223 in combination with weekly doses of GLP-1 analogue for four weeks. The study also included a five-month follow-up period.

Transition said its broad in-licensing and collaboration agreement with Lilly will not be affected by the termination of the TT-223 development programme. The deal, which was announced in March of this year, gives Transition exclusive worldwide rights to a series of Lilly's pre-clinical drug candidates for diabetes and related co-morbid conditions. Lilly retains the option to re-acquire the rights to the compounds later in their development.

The Lilly drugs represent a new class of compounds that, in pre-clinical diabetes models, showed potential to provide glycaemic control and weight loss.

The deal signed this year built on a pre-existing partnership between the two companies in the area of gastrin-based therapies for diabetes developed by Transition. That collaboration, which was formed in 2008, granted Lilly exclusive worldwide rights to develop and commercialise Transition's gastrin based therapies, including TT-223.

Toronto-based Transition does not yet have any marketed products. Its lead product in development is a phase III drug for Alzheimer's disease.