Promising results with Lu AE58054 as add-on to donepezil, in cognitive symptoms of Alzheimer's disease

Danish CNS specialist Lundbeck (LUN: CO) and Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) presented  the first clinical data on the investigational drug Lu AE58054, a selective 5-HT6 receptor antagonist, in Alzheimer's disease at the Alzheimer's Association International Conference 2013 (AAIC 2013) in Boston, USA.

The Phase II clinical study demonstrated that treatment with Lu AE58054 as add-on to donepezil (Eisai and Pfizer’s Aricept) for six months improved cognitive performance in patients with moderate Alzheimer's disease (2.16 points improvement on ADAS-Cog at 24 weeks, p=0.004). The companies plan to initiate a Phase III clinical program in about 3,000 patients during the second half of 2013.

The two companies' focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the research to date on Alzheimer's disease.