Date: 2012-07-23
Type of information: Results
phase: 3
Announcement: results
Company: Pfizer (USA - NY) Janssen AI Elan (Ireland)
Product: bapineuzumab
Action
mechanism: Bapineuzumab is an antibody that targets beta-amyloid protein.
Disease: mild-to-moderate Alzheimer’s disease in patients who carry the ApoE4 (apolipoprotein E epsilon 4) genotype
Therapeutic area: Neurodegenerative diseases
Country:
Trial
details: Study 302 is the first of four placebo-controlled Phase 3 studies to complete in the comprehensive development program of bapineuzumab IV. Janssen AI is leading two 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients who are ApoE4 carriers (Study 302) and Apoe4 non-carriers (Study 301). The two co-primary clinical endpoints are change in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a validated measure of cognition, and the Disability Assessment for Dementia (DAD), a validated instrument to measure function.
Study 302 included approximately 1,100 patients who carry the ApoE4 genotype and Study 301 includes approximately 1,300 patients who do not carry the ApoE4 genotype.
In addition to the Janssen AI-led studies, Pfizer is conducting two primarily ex-North America 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients with mild-to-moderate Alzheimer’s disease who are ApoE4 non-carriers (Study 3000) and carriers (Study 3001).
Latest
news: Pfizer has announced 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 carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 302). Pfizer and Janssen AI are partners in the Alzheimer’s Immunotherapy Program (AIP).
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.
Based on a comprehensive review of the data by the independent safety monitoring committee, all other ongoing Janssen AI and Pfizer bapineuzumab studies are continuing as planned and without modifications. The Alliance will expedite the completion of an interim analysis for the on-going, Pfizer-conducted Phase 3 study of ApoE4 carriers (Study 3001) based on the results of Study 302.
The topline results from Study 301 in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype are expected to be announced later this summer.
Data from both the ApoE4 carrier (Study 302) and non-carrier (Study 301) studies have been accepted as a late-breaker and will be presented in September at the European Federation of Neurological Societies meeting in Stockholm.
