Phase III trial of Lu AE 58054 (idalopirdine) shows weak efficacy in alzheimer's disease- Lunbeck

Lundbeck announced the headline conclusions from the first clinical phase III study, STARSHINE, in the ongoing phase III programme evaluating the efficacy of the investigational drug Lu AE 58054 (idalopirdine) for the symptomatic treatment of patients with mild to moderate Alzheimer�s disease. In the STARSHINE 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.

In addition, the secondary endpoints also did not show separation from placebo. The overall safety profile for idalopirdine showed that idalopirdine was safe and well tolerated. Further analysis of the data is ongoing. The two remaining studies, STARBEAM and STARBRIGHT, in the phase III programme that currently are ongoing will continue as planned and data are expected in the first quarter of 2017.