Transition Therapeutics Announces Results of Phase 1 Clinical Study of TT-401
Transition Therapeutics (Nasdaq: TTHI) announced the results of a single ascending dose escalation study of TT-401, a type 2 diabetes drug candidate. TT-401 is a once-weekly administered peptide being studied for its potential to lower blood glucose levels in patients with type 2 diabetes and accompanying obesity. TT-401 is a dual agonist of the GLP-1 (Glucagon-Like Peptide-1) receptor and a second metabolic target.
The Phase 1, double-blind, placebo-controlled randomized study enrolled 48 non-diabetic obese subjects in six cohorts evaluating six escalating subcutaneous single doses of TT-401. TT-401 demonstrated an acceptable safety and tolerability profile in non-diabetic obese subjects in the study. TT-401 exhibited the expected pharmacological effect on glucose and pharmacodynamic biomarkers at doses that were safe and tolerable. The pharmacokinetic profile, assessed over 28 days, demonstrated a half-life consistent with once-weekly dosing.
As the study results have met expectations, Transition and its development partner, Eli Lilly and Company have jointly decided that the next development step will be a multiple ascending dose study of TT-401 in obese subjects with type 2 diabetes.
In March 2010, Transition entered into a licensing and collaboration agreement with Lilly, where Transition acquired the rights to a series of pre-clinical Lilly compounds, including TT-401 for the treatment of type 2 diabetes.
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