Otsuka, Lundbeck Present Lu AE58054 Phase II Data For Alzheimer’s Disease

H. Lundbeck A/S and Otsuka Pharma announced Phase II clinical data on their Lu AE58054 investigational drug for moderate Alzheimer’s disease.

AsianScientist (Jul. 22, 2013) – H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announced this month data from a Phase II clinical study demonstrating that treatment with Lu AE58054 as add-on to donepezil for six months improved cognitive performance in patients with moderate Alzheimer’s disease.

The companies announced the first clinical data at the Alzheimer’s Association International Conference 2013 in Boston. Following the AAIC, an abstract of the July 16 presentation will be published in the journal Alzheimer’s and Dementia.

“I am very pleased with the data achieved in this project. Lu AE58054 potentially represents a new approach to Alzheimer’s disease and a continuation of Lundbeck’s commitment to addressing this complicated disease”, says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. “It is my hope that the clinical phase III program will confirm results seen from this phase II trial, and demonstrate a positive outcome on this devastating 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.

In addition, 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.

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.

The companies have planned a Phase III clinical study for the second half of 2013. Approximately 3,000 patients with Alzheimer’s disease are expected to be enrolled in the study. Several doses of Lu AE58054 will be used in combination with donepezil in order to explore in mild-to-moderate dementia of the Alzheimer’s type as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). The program will enroll patients globally and is expected to last up to three years.

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Source: H. Lundbeck A/S.
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