Topline results from Janssen bapineuzumab Phase 3 trial on mild-to-moderate Alzheimer's

Pfizer Inc. (NYSE: PFE) announced today that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 301). Pfizer and Janssen AI are partners in the Alzheimer's Immunotherapy Program (AIP).    

Based on the topline results of this study, together with the topline results of a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype (Study 302)announced on July 23^rd, the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided to discontinue all other bapineuzumab IV studies in patients with mild-to-moderate Alzheimer's disease. This includes not only the Pfizer-led, Phase 3 studies (Study 3000 and Study 3001), but also all follow-on extension studies in patients with mild-to-moderate Alzheimer's disease receiving bapineuzumab IV. All patients in the discontinued studies will have a follow-up evaluation and the Alliance will conduct final data analyses.

These clinical findings and the decision to discontinue the bapineuzumab IV program in patients with mild-to-moderate Alzheimer's disease have been shared with regulatory authorities and study investigators.

"We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer's disease and their caregivers," said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. "Yet these data, and the subgroup and biomarker analyses underway, will further inform our understanding of this complex disease and advance research in this field."

No new safety concerns were identified in Study 301. The most commonly observed serious adverse events which occurred in bapineuzumab-treated patients more commonly than in placebo-treated patients, and with an incidence of at least 1 percent in the combined 0.5 mg/kg and 1.0 mg/kg group, were pneumonia, ARIA-E (amyloid-related imaging abnormalities-edema or effusion), syncope, hip fracture and convulsion.

Data from both Study 302 and Study 301 have been accepted as a late-breaker and will be presented in September at the European Federation of Neurological Societies (EFNS) meeting in Stockholm.