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  5. Headline conclusions from the phase III study of idalopirdine (Lu AE58054) for cognitive symptoms associated with Alzheimer's disease

September 26, 2016

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Headline conclusions from the phase III study of idalopirdine (Lu AE58054) for cognitive symptoms associated with Alzheimer's disease

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the headline conclusions from the first phase III clinical study of idalopirdine (STARSHINE study) in the ongoing phase III program evaluating the efficacy of the investigational drug idalopirdine for the treatment of patients with cognitive symptoms associated with mild to moderate Alzheimer's disease. Idalopirdine, co-developed with Lundbeck, did not meet its primary efficacy endpoint in the study.

Idalopirdine showed a weak efficacy profile as neither of the two dosages used in the study met the primary endpoint of a reduction in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score when added to donepezil. The secondary endpoints also did not show separation from placebo. The overall safety profile for idalopirdine in the study showed that it was safe and well tolerated. Further analysis of the data is ongoing.

Results from two other phase III studies (STARBEAM and STARBRIGHT) are expected in 2017.


Information in this news release was current as of the original release date.

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