Lundbeck has announced that the first late-stage trial of its experimental Alzheimer’s disease candidate idalopirdine failed to hit its primary targets.
Data from the Phase III STARSHINE study show a weak efficacy profile for the drug, with neither of the two doses tested inducing a significant reduction in the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) total score when added to donepezil.
In a further blow, secondary endpoints also failed to show a difference from placebo, although the drug was found to be safe and well tolerated, the firm said.
“We are disappointed about the outcome of this study,” said Dr Anders Gersel Pedersen, EVP and chief scientific officer at Lundbeck. “The Phase II data were very encouraging but unfortunately, these data failed to replicate those findings”.
Two other studies in the Phase III programme – STARBEAM and STARBRIGHT – will continue as planned with data expected in the first quarter of next year, the Danish drugmaker noted.
