Elan and Wyeth present ‘encouraging’ phase II bapineuzumab results

Elan and Wyeth have presented phase II clinical trial results of bapineuzumab at the international conference of the Alzheimer’s Disease Association in Chicago.

The companies reported that the safety and efficacy results of the study support the design of the ongoing phase III clinical programme.

In the study, vasogenic edema was found to correlate witth ApoE4 carrier status and dose, which influenced the design of the phase II programme.

The pre-specified efficacy analysis of the study did not reach significance in the total population, though in the post-hoc analysis, trends were observed in the cognitive endpoints ADAS-cog and NTB in the total population.

Furthermore, clinically meaningful and statistically significant effects were seen in a number of endpoints in ApoE4 no-carriers, while in ApoE4 carriers favourable directional changes were seen in some of the endpoints.

Sid Gilman, director of Michigan Alzheimer’s Disease Research Centre at the, University of Michigan, said: “This study was limited in its size, design and goals.”

He added despite this, if the findings seen in the post-hoc analyses are present in the phase III programme, it would validate the amyloid hypothesis and alter the way Alzheimer’s disease is treated.

Last month, Wyeth said it was “encouraged” by the phase II clinical trial results for bapineuzumab.