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Transition Therapeutics Diabetes Drug Candidate, TT-401, Commences Phase 2 Clinical Study

May 15, 2014

TORONTO, May 15, 2014 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX: TTH) today
announced the dosing of the first patient in a Phase 2 clinical study
of TT-401 (LY2944876), a drug candidate for the treatment of type 2
diabetes. The study is expected to enroll up to 375 type 2 diabetes
subjects and will be performed by Transition’s development partner, Eli
Lilly and Company (“Lilly”). The objectives of the study will be to
evaluate the safety and effectiveness of TT-401 compared to once-weekly
exenatide extended release and placebo.

The randomized, double-blind, placebo-controlled study will include six
study arms, four doses of TT-401, a placebo arm and a once-weekly
exenatide arm. The study will include a 12-week blinded treatment
period, where neither the participant nor the investigator will know
which treatment each individual is assigned. Thereafter follows a
12-week period (weeks 13-24) where participants and the investigator
will know which treatment they are assigned to. Participants on TT-401
and on once-weekly exenatide will continue treatment through weeks
13-24, and those who received placebo will be followed without
treatment.

The main efficacy outcome measures will be the change in HbA1c (a
measure of blood-glucose levels) at week 12 and 24 and change in body
weight over the course of the study. Additional information on the
study and participation can be found at clinicaltrials.gov under study#
NCT02119819.

About TT-401 (LY2944876)

TT-401 is being developed to treat type 2 diabetes. The TT-401
(LY2944876) drug candidate is an oxyntomodulin analog that has dual
agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon
receptors. In March 2010, Transition licensed a series of pre-clinical
compounds from Lilly, including TT-401. In June 2013, Lilly exercised
its option to assume all development and commercialization rights of
TT-401.

About Transition

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 Down
syndrome. 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.


Source: PR Newswire



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