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Transition Therapeutics, Inc.

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Dr. Tony Cruz, Chief Executive Officer, commented on the timing for data from the phase-II trial with ELND-005 in AD. He stated, "Aggression in Alzheimer's patients is considered a major problem for caregivers and a major cost for the health care system. It is the major reason why AD patients or Alzheimer's patients are institutionalized. The 400-patient aggression trial is a placebo-controlled safety and efficacy study with primary endpoints being severity of aggression following a 12-week trial or 12 weeks of treatment. According to clinicaltrials.gov, the efficacy trial is expected to be completed by the end of the year."
Source: Q3 FY 2013 earnings conference call, 5/07/13.

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Transition Therapeutics Announces Enrollment of the First Patient in Phase 2 Study of ELND005 (Scyllo-inositol) for the Treatment of Agitation/Aggression in Patients with Alzheimer's Disease

- Approximately 90% of AD patients develop neuropsychiatric symptoms
- Approximately 60% of AD patients develop agitation/aggression

TORONTO, ON, November 28th, 2012 - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) today announced its licensing partner, Elan Corporation, plc ("Elan") has enrolled the first patient in a Phase 2 study of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease (AD).

The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and potentially other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific neuropsychiatric symptoms, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. More information on Study ELND005-AG201 will be available at http://www.clinicaltrials.gov/.
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Source: press release, 11/28/12. http://www.transitiontherapeutics.com/media/news.php

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ELND005 (AZD-103) for Alzheimer's Disease

Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.

The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL) in mild to moderate patients. The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 2/09/12. http://www.transitiontherapeutics.com/media/news.php

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ELND005 (AZD-103) for Alzheimer's Disease

Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.

The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL) in mild to moderate patients. The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 9/19/11. http://www.transitiontherapeutics.com/media/news.php

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The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL). The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 5/10/11. http://www.transitiontherapeutics.com/media/news.php

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TORONTO, Dec. 27, 2010 -- Transition Therapeutics Inc. ("Transition" or "Company") (TSX:TTH) (Nasdaq:TTHI) today announced that the Company and Elan Corporation, plc ("Elan") (NYSE:ELN) have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.
Source: press release, 12/27/10. http://www.transitiontherapeutics.com/news/article.php

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01735630?term=ELND005&rank=4

Mechanism of action: ELND-005 (AZD-103), a SM, reduces disease progression and improves symptoms such as cognitive function via the break down of neurotoxic fibrils, allowing amyloid peptides to clear the body rather than form amyloid plaques.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2013-12-01 - 2014-03-31

Results: Pending