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Transition Therapeutics, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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TT401 (LY2944876) is an oxyntomodulin analogue that has dual agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors. A Phase 2 clinical trial of TT401 in type 2 diabetes subjects is being performed by Transition’s development partner, Lilly. Results from this study are expected in calendar Q4 2015.
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Source: press release, 5/12/15. http://www.transitiontherapeutics.com/media/press_releases/20150512.pdf

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

TORONTO, ON, May 15th, 2014 - 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.
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Source: press release, 5/15/14. http://transitiontherapeutics.com/media/news.php

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Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
Estimated Enrollment: 375
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02119819?term=NCT02119819&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
TT-401 (LY2944876)Endocrine and MetabolismDiabetes type IIGLP-1 and glucagon receptor agonistGLP-1 and glucagon receptors

Mechanism of action: TT-401 (LY2944876) is an oxyntomodulin analog that has dual agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2015-10-01 - 2015-12-31

Results:

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Transition Therapeutics Announces Top Line Phase 2 Clinical Study Results of Diabetes Drug Candidate TT401

TORONTO, ON, February 1, 2016 – Transition Therapeutics Inc. (“Transition” or the “Company”)
(NASDAQ: TTHI, TSX: TTH) today announced the results of a Phase 2 clinical study of drug candidate
TT401 (LY2944876) for the treatment of type 2 diabetes. TT401 is a once-weekly administered
oxyntomodulin analog with dual GLP-1 and glucagon agonist activity. TT401 development collaborator
Eli Lilly and Company performed the Phase 2 study enrolling 420 type 2 diabetes subjects into a 24 week
study consisting of a 12-week randomized blinded stage followed by a 12-week open-label stage. The
study included four once-weekly dose arms of TT401 (10mg, 15mg, 30mg, 50mg), a placebo arm, and an
active comparator arm (exenatide extended release – 2mg).

TT401 demonstrated HbA1c improvements of up to -1.43% (similar to the exenatide arm). All TT401
dose arms and the exenatide arm were statistically significant relative to the placebo arm at Weeks 12 and
24.

TT401 also produced dose dependent weight loss (up to -3.3 kg). The weight loss observed in the highest
dose arm (50mg of TT401) was statistically significant relative to both the placebo and exenatide arms at
weeks 12 and 24.

In the study, TT401 appeared to have an acceptable safety and tolerability profile. There were a similar
number of study discontinuations and serious adverse events between the TT401 dose arms and the
exenatide arm. The most frequently observed adverse events were gastrointestinal; these were generally
classified as mild to moderate and diminished over time.

The Phase 2 study data will be submitted for presentation at a future medical meeting.
Should Lilly continue TT401 development, Transition would be eligible to receive a milestone payment
as well as future milestone payments and royalties. Otherwise, Transition may elect to assume
development and commercialization rights to TT401. This option allows Transition to pursue TT401
development on its own or with a third party, subject to future royalty payments to Lilly
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Source: press release, 2/01/16. http://www.transitiontherapeutics.com/media/press_releases/20160201.pdf

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