Transition Therapeutics Announces Results of Clinical Study of Type 2 Diabetes
Drug Candidate TT-401
TORONTO, April 30, 2013
TORONTO, April 30, 2013 /PRNewswire/ - Transition Therapeutics Inc.
("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) 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.
"We are very pleased with the proof of concept data from this study. This new
dual agonist that targets GLP-1 and a second metabolic mechanism shows
promising effects on weight loss and glycemic control and could provide
broader therapeutic benefit to patients with type 2 diabetes. These data
support a clear development path forward to a larger Phase 2 efficacy study of
TT-401," said Dr. Aleksandra Pastrak, Vice President, Clinical Development and
Medical Officer of Transition.
TT-401 is a dual agonist of the GLP-1 (Glucagon-Like Peptide-1) and glucagon
receptors. In March 2010, Transition entered into a licensing and
collaboration agreement with Eli Lilly and Company, where Transition acquired
the rights to a series of pre-clinical compounds from Lilly, including TT-401
for the treatment of type 2 diabetes.
Transition is a biopharmaceutical company, developing novel therapeutics for
disease indications with large markets. The Company's lead CNS drug candidate
is ELND005 for the treatment of Alzheimer's disease and bipolar disorder.
Transition's lead metabolic drug candidate is TT-401 for the treatment of type
2 diabetes and accompanying obesity. The Company's shares are listed on the
NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol
"TTH". For additional information about the Company, please visit
Notice to Readers: Information contained in our press releases should be
considered accurate only as of the date of the release and may be superseded
by more recent information we have disclosed in later press releases, filings
with the OSC, SEC or otherwise. Except for historical information, this press
release may contain forward-looking statements, relating to expectations,
plans or prospects for Transition, including conducting clinical trials and
potential efficacy of its products. These statements are based upon the
current expectations and beliefs of Transition's management and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include factors beyond Transition's control and the risk
factors and other cautionary statements discussed in Transition's quarterly
and annual filings with the Canadian commissions.
SOURCE Transition Therapeutics Inc.
For further information on Transition, visitwww.transitiontherapeutics.com or
Dr. Tony Cruz
Chief Executive Officer
Transition Therapeutics Inc.
Phone: 416-260-7770, x.223
Press spacebar to pause and continue. Press esc to stop.