Transition Therapeutics Shares Sharply Higher as Data from TT-401 in Type 2 Diabetes Better Than Expected

Transition Therapeutics Inc. ("Transition" or the "Company")

announced the results of a five-week proof of concept clinical study of TT-401 in type 2 diabetic and obese non-diabetic subjects.  In the study, TT-401 a once-weekly administered peptide, demonstrated significant improvements in glycemic control and reductions in body weight. The study enrolled diabetic patients at five dosing levels and non-diabetic obese patients at one dose level.  All dosing cohorts received five doses over a five week period.  Diabetic patients were on stable doses of metformin.  At the end of the treatment period, TT-401-treated patients in the three highest dose groups experienced statistically significant reductions in mean fasting plasma glucose relative to placebo. Statistically significant mean body weight reduction relative to baseline occurred in the three highest dose groups.  A similar reduction in body weight was also observed in the obese non-diabetic cohort. TT-401 demonstrated an acceptable safety and tolerability profile at all doses evaluated in diabetic and non-diabetic obese subjects.  The most common adverse event noted in the study was decreased appetite.  Some subjects in the highest three dose groups experienced mild nausea and vomiting, which are consistent with studies of other GLP-1 agonist drug candidates.  The pharmacokinetic profile, assessed over the five week study, demonstrated a half-life consistent with once-weekly dosing.