Date: 2012-10-11
Type of information: Results
phase: 2b
Announcement: results
Company: Noscira, grupo Zeltia (Spain)
Product: tideglusib
Action
mechanism: GSK-3 inhibitor. Tideglusib belongs to a family of compounds that inhibit the GSK-3 enzyme, which is overexpressed in people with Alzheimer\'s disease, and it acts on the two main cell processes that cause the disease: tau hyperphosphorylation and 6-amyloid aggregation. Tideglusib is the only GSK-3 inhibitor in clinical development, and is therefore an innovative alternative to currently available treatments.
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: Spain, UK, France, Finland and Germany
Trial
details: 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.
Latest
news: * On October 11, 2012, Noscira, a subsidiary of Grupo Zeltia focused on developing innovative treatments for neurodegenerative diseases, has announced that the primary cognitive end-point and two of the secondary end-points were not met in the 26 week ARGO Phase IIb trial. This study evaluated the efficacy of tideglusib versus placebo plus standard of care for the treatment of mild-to-moderate Alzheimer’s disease (AD).
Tideglusib, a GSK-3 inhibitor, was relatively well-tolerated in the 306 patient study. No new safety concerns were detected. Pending analyses of the other secondary end-points, subpopulations, biomarkers and magnetic resonance image (MRI) substudy will be completed in the following weeks.
* On June 12, 2012, Noscira has announced that it had received the conclusions of the third Data and Safety Monitoring Board (DSMB) meeting, held on 30 May, for the ARGO trial. The independent board, comprising two hepatologists and a neurologist, reviewed the data on the 306 randomised patients who have been/are being treated in the trial. After evaluating the safety data, the DSMB recommended that the trial continue without modifications. It is advancing on schedule, and preliminary results are expected before the end of this year.
* On January 18, 2012, Noscira has 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. 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).
