Lundbeck says its investigational Alzheimer's disease drug Lu AE58054 has met its primary endpoint in a mid-stage study.
The Phase II trial was conducted in 278 patients suffering from moderate Alzheimer's and Lu AE58054 was administered as add-on to Eisai/Pfizer's blockbuster dementia drug Aricept (donepezil). The Danish drugmaker's treatment plus donepezil demonstrated significant improvements in cognitive function in Alzheimer's disease compared to placebo plus donepezil.
Lundbeck noted that secondary endpoints, including measures of global status and activities of daily living also showed positive trends with the addition of Lu AE58054, compared with patients who only received Aricept. The new drug was also considered to be well tolerated at the selected dose.
Head of R&D, Anders Gersel Pedersen, said the results are very encouraging "and we are now evaluating how to best proceed with the development of Lu AE58054". The firm is looking at a major pivotal clinical programme "potentially including development and commercial partnerships".
Lu AE58054 is a novel, selective 5HT6 receptor antagonist with a different mechanism of action than currently-available Alzheimer's medications.