Zeltia of Spain says it is making good progress with its investigational Alzheimer's disease tideglusib.
The Madrid-headquartered firm's Noscira unit has received the conclusions of the third data and safety monitoring board meeting for the Phase II ARGO trial. The DSMB has recommended that the study continue without modifications and preliminary results are expected before the end of this year.
Tideglusib, a glycogen synthase kinase 3 (GSK-3) inhibitor, is administered orally in daily doses for 26 weeks, with the possibility of an extension of the double-blind trial to 15 months. The drug, also known as NP-12, is currently the only compound in clinical development for AD which acts directly on hyperphosphorylation of the tau protein.
All patients in both groups will also receive baseline treatment with drugs that are already approved for AD. The trial involves 306 randomised patients at 55 hospitals in Spain, the UK, France, Finland and Germany.
Zeltia notes that tideglusib "has proven to be capable of acting on several of the histopathological lesions associated with the disease in experimental models". It reduces phosphorylation of the tau protein and hippocampal and entorhinal cortex neuron loss, improves spatial memory deficits and significantly reduces the accumulation of amyloid plaques in the brain. Tideglusib "also provides neuroprotection in vivo and has a potent anti-inflammatory effect in a range of animal models".