Lundbeck and Otsuka progress new add-on treatment for Alzheimer's

Denmark-based CNS specialist Lundbeck (LUND: CO) and partner Japan’s Otsuka Pharmaceutical (TYO: 4768) have announced the continuation of the development program of Lu AE58054 for the treatment of Alzheimer's disease, initiating the first out of four currently planned Phase III clinical trials with the compound in Alzheimer's disease.

Lu AE58054 is a selective 5HT6 receptor antagonist with a different proposed mechanism of action than currently available Alzheimer's medications. Notably, a focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the drug research to date on Alzheimer's disease.

Lundbeck and Otsuka are now initiating the Phase III program which is currently planned to consist of four trials. Several doses of Lu AE58054 ranging from 10mg-60mg will be used in combination with donepezil in order to explore the effect of the compound in mild-to-moderate Alzheimer's disease as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). The key endpoints are Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog), Activities of Daily Living (ADL), and the Clinical Global Impression of Change Scale (CGIC).