Otsuka Pharmaceutical Co., Ltd.

September 26, 2016

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

  • Idalopirdine, co-developed with Lundbeck, did not meet the primary endpoint in the first of three phase III studies
  • Idalopirdine was safe and well tolerated
  • Clinical study data are expected from the remaining two phase III studies in the first quarter of 2017

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.