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