Transition Therapeutics Announces Results of Clinical Study of Type 2 Diabetes Drug Candidate TT-401
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
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 www.transitiontherapeutics.com.
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.