An anonymous director reports

TRANSITION THERAPEUTICS ANNOUNCES ENROLMENT COMPLETION OF ELND005 PHASE 2 CLINICAL STUDY IN AGITATION AND AGGRESSION IN PATIENTS WITH ALZHEIMER'S DISEASE

Transition Therapeutics Inc.'s wholly owned subsidiary, Transition Therapeutics Ireland Ltd., has completed enrolment of the phase 2 clinical study evaluating neuropsychiatric drug candidate ELND005 as a treatment for agitation and aggression in patients with mild, moderate and severe Alzheimer's disease. The objectives of the phase 2 clinical study are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with mild to severe AD who are experiencing at least moderate levels of agitation/aggression. The randomized, double-blind, placebo-controlled study has enrolled 350 AD patients at 69 clinical sites in the United States, Canada, Spain and the United Kingdom. The primary efficacy end point of the study is the change from baseline in the Neuropsychiatric Inventory -- Clinician scale of agitation and aggression. It is anticipated that the top-line data from the Harmony AD study will be announced midyear 2015.

About ELND005

ELND005 is an orally bioavailable small molecule that is being investigated for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes s-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical program of phase 1 and phase 2 studies has been completed with ELND005 to support clinical development. ELND005 is being studied as a potential treatment of agitation and aggression in Alzheimer's disease and as a therapy for those with Down syndrome. ELND005 has received fast-track designation from the psychiatry division of the United States Food and Drug Administration for its potential as a treatment of neuropsychiatric symptoms (including agitation and aggression) in AD.

About neuropsychiatric symptoms and Alzheimer's disease

It is currently estimated that approximately 5.4 million Americans and approximately 7.2 million Europeans have AD, and these numbers are expected to rise to 16 million by 2050. AD is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgements, communicate and carry out daily activities. Approximately 90 per cent of AD patients develop neuropsychiatric symptoms, and up to 60 per cent develop agitation and aggression over the course of their disease. Agitation and aggression are among the most disruptive neuropsychiatric symptoms in AD and are associated with increased mortality, morbidity and caregiver burden.

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