Elan Corporation, the licensing partner of Transition Therapeutics Inc., has enrolled the first patient in a phase II study of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease (AD). The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and potentially other selected regions.

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. In the phase II 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.

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/aggression over the course of their disease. Agitation/aggression are among the most disruptive NPS in AD and are associated with increased morbidity and caregiver burden.

ELND005 is an orally bioavailable small molecule that is being investigated by Transition's licensing partner, Elan, for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes:-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical programme of phase I and phase II studies have been completed with ELND005 to support clinical development, including the recently published phase II study ELND005-AD201 in AD. ELND005 is also being studied as a maintenance treatment of Bipolar Disease in an ongoing study (Study ELND005-BPD201).

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets.