Alzheimer's drug candidate Lu AE58054 meets primary endpoint, says Lundbeck

Danish CNS drug specialist Lundbeck (LUND: DC) announced this morning that its investigational compound 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 novel, selective 5HT6 receptor antagonist with a different mechanism of action than currently available Alzheimer's medications.

Alzheimer’s disease drug market in seven major markets (the USA, France, Germany, Italy, Spain, the UK and Japan) will nearly triple, from $5.4 billion in 2010 to $14.3 billion in 2020, according to a report from Decision Resources. The sector is presently dominated by symptomatic therapies such as acetylcholinesterase inhibitors - eg Eisai/Pfizer's Aricept (donepezil), Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) - and N-methyl-D-aspartate (NMDA) receptor antagonists, namely memantine, sold by Forest Laboratories, Lundbeck and Daiichi Sankyo.

Lundbeck noted that 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. Treatment with Lu AE58054 in this study was well tolerated.