Lundbeck compound reaches primary endpoint in Phase 2 trial
Tuesday 29 May 2012
On 29 May, Danish drug company Lundbeck announced that Lu AE58054 has met its primary endpoint in a fixed dose, randomized, placebo-controlled clinical study in 278 patients suffering from Alzheimer's disease. Lu AE58054 is a selective 5HT6 receptor antagonist.
Augmentation therapy with Lu AE58054 (plus10mg/day donepezil) at the selected dose resulted in statistically significant improvement in cognition, as measured by the ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive sub-scale) over a 24 week treatment period versus placebo (plus10mg/day donepezil). 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 donepezil.
Lundbeck is now evaluating the future development strategy of Lu AE58054 with the intention to initiate a major pivotal clinical programme.