ZELTIA NEWS

Noscira completes randomisation of patients with Alzheimer's disease in its ARGO Phase II trial with tideglusib

The completion of randomisation on schedule is a major milestone as it will allow for the results to be ready at the end of 2012.

The ARGO trial involves 308 patients at 55 hospitals in five

European countries.

Tideglusib is currently the only compound in clinical development for

Alzheimer's disease which acts directly on the tau protein.

Madrid, 18 January 2012: Today Noscira announced the completion of randomisation of patients with Alzheimer's disease (AD) for its Phase II trial with tideglusib. The trial is advancing on schedule, and preliminary results are expected at the end of this year.

The trial, called ARGO (Alzheimer's Research in GSK-3 mOdulation), investigates the effects of tideglusib versus placebo. Under the trial, tideglusib, a GSK-3 inhibitor, is administered orally in daily doses for 26 weeks, with the possibility of an extension of the double-blind trial for up to 15 months (until the last patient in the trial completes 26 weeks of treatment). All patients in both groups will also receive baseline treatment with commercially-available drugs that are approved for AD. This clinical trial involves 308 patients at 55 hospitals in Spain, the UK, France, Finland and Germany.

Inclusion criteria were based on a diagnosis of Alzheimer's disease, an age of 50 to

85, a score between 14 and 26 on the Mini-Mental State Examination (MMSE), and treatment in stable well-tolerated doses with an acetylcholinesterase inhibitor and/or memantine.

The primary efficacy criteria in the ARGO trial is the comparison of the change with respect to the basal situation in the ADAS-Cog plus scale in groups with active treatment versus the placebo group. The trial will also analyse several secondary cognitive, functional and quality of life variables. Changes in neuroimaging and biomarkers will be studied as exploratory variables (in a sub-group of patients in pre-defined hospitals).

Tideglusib belongs to a family of compounds that inhibit the GSK-3 enzyme, which is overexpressed in people with AD, and it acts on the two main cell processes that cause the disease: tau hyperphosphorylation and