Elan/Wyeth Ph II AD drug misses endpoint but Ph III going ahead

USA-based drug major Wyeth and Irish drugmaker Elan's Alzheimer's disease drug candidate, bapineuzumab, has failed to reach statistical significance for the primary endpoint of a Phase II trial, but the firms say the drug will advance to Phase III on a post-hoc analyses of subgroups.

The trial was a randomized, double-blind, placebo-controlled, multiple ascending-dose study of patients with mild-to-moderate Alzheimer's disease. In non-carriers of the Apolipoprotein E4 (ApoE4) allele, estimated to be from 40% to 70% of the Alzheimer's population, post-hoc analyses of MRI results showed less loss of brain volume among treated patients versus placebo patients. The clinical significance of this finding is currently unclear and analyses are ongoing. The companies believe that the overall safety findings from this Phase II trial support their prior decision to move to Phase III studies.

Bernard Poussot, chief executive of Wyeth said the firms "recognize there is a great deal of hard work left as we move from this phase of learning towards confirming the potential of bapineuzumab."