Pfizer and Janssen's bapineuzumab fails to meet one Ph III study endpoints for Alzheimer's

US drugs behemoth Pfizer (NYSE: PFE) revealed yesterday that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the first of four Phase III studies of bapineuzumab conducted by partner Janssen, part of health care giant Johnson & Johnson (NYSE: JNJ), in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 302). Pfizer’s shares fell 1.5% to $23.25 in after-hours activity, while those of J&J dipped 0.4% in after-hours trading.

Because in this study clinical efficacy was not demonstrated in ApoE4 carriers, the Janssen and Pfizer Joint Steering Committee for the Alzheimer’s Immunotherapy Program (AIP), on which the companies are partnered, has decided that participants from this trial who enrolled in a follow-on extension study will no longer receive doses of bapineuzumab. However, these patients will have a follow-up evaluation. Based on a comprehensive review of the data by the independent safety monitoring committee, all other ongoing Janssen and Pfizer bapineuzumab studies are continuing as planned and without modifications.

Study 302 is the first of four placebo-controlled Phase III trials to complete in the comprehensive development program of bapineuzumab IV. Janssen 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 trials of patients who are ApoE4 carriers (Study 3001) and non-carriers (Study 3000) at sites primarily outside of North America.