Phase III study of bapineuzumab (Janssen Alzheimer Immunotherapy) for Alzheimers Disease fails to meet endpoint

In a Phase III trial of intravenous bapineuzumab, from Janssen Alzheimer Immunotherapy, in patients with mild-to-moderate Alzheimer�s disease who carry the ApoE4 genotype (Study 302), the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met. Study 302 is the first of four placebo-controlled Phase III studies to complete in the development of bapineuzumab IV.

These clinical findings have been shared with regulatory authorities and study investigators so that participants in the ongoing clinical program can be informed. Because in this study clinical efficacy was not demonstrated in ApoE4 carriers, the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided that participants from this study who enrolled in a follow-on extension study will no longer receive doses of bapineuzumab. However, these patients will have a follow-up evaluation.

Janssen AI is leading two Phase III studies of patients who are ApoE4 carriers (Study 302) and non-carriers (Study 301) at sites primarily in North America. Pfizer is conducting two Phase III studies of patients who are ApoE4 carriers (Study 3001) and non-carriers (Study 3000) at sites primarily outside of North America. The Alliance will expedite the completion of an interim analysis for the on-going, Pfizer-conducted Phase III study of ApoE4 carriers (Study 3001) based on the results of Study 302. Data from both the ApoE4 carrier (Study 302) and non-carrier (Study 301) studies will be presented in September at the European Federation of Neurological Societies meeting in Stockholm.