Tuesday, July 16, 2013

Lu AE58054 demonstrates benefit in Alzheimer disease

Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the presentation of the first clinical data on the investigational drug Lu AE58054 in Alzheimer’s disease at the Alzheimer’s Association International Conference 2013 (AAIC 2013) in Boston.

Lu AE58054 is a selective 5-HT6 receptor antagonist under investigation for the treatment of Alzheimer's disease. The phase II clinical study demonstrated that treatment with Lu AE58054 as add-on to donepezil for six months improved cognitive performance in patients with moderate Alzheimer’s disease.

This phase II clinical study exploring the efficacy and safety of Lu AE58054 as add-on to donepezil was a multi-center, randomized, double-blind, parallel-group, placebo-controlled trial for a period of 24 weeks. The study was conducted in 278 patients with moderate Alzheimer’s disease in Europe, Canada and Australia.

Lu AE58054 plus donepezil demonstrated significant improvements in cognitive function in Alzheimer's disease compared to placebo plus donepezil:.
  • Addition of Lu AE58054 (90 mg/day) to stable donepezil treatment resulted in improved cognitive performance as measured by the primary endpoint ADAS-Cog at Week 24 (p=0.004). The mean difference in ADAS-Cog at Week 24 was -2.16 (95% confidence interval of -3.62 to -0.69). The effect was apparent after 12 weeks.
  • Secondary efficacy assessments including ADCS-CGIC and ADCS-ADL23 showed a trend in favor of Lu AE58054 treatment at Week 24 compared with patients who only received donepezil, but the differences were not statistically different. The study was not designed to show statistically significant differences for these secondary endpoints.
  • Treatment with Lu AE58054 was generally well tolerated. Liver enzyme (ALT, AST, GGT) elevations were observed in some patients. Changes in transaminases were asymptomatic and returned towards baseline values in patients who either continued treatment or withdrew from the study

Market Opportunity

If the liver enzyme elevation issue is manageable ( either by a lower dose or by routine management), the efficacy benefit is very significant and Lu AE58054 could be a multi-billion dollar opportunity. Efficacy is  currently a major unmet need in the treatment of Alzheimer patients and this would be a meaningful addition to the treatment armamentarium.  The now generic Aricept generated $3.9bn at peak despite relatively modest benefits.

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