NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) 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 or Janssen AI-led Phase 3 trial of intravenous or 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.
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 company said that 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.
Bapineuzumab IV, an investigational therapy being studied for the treatment of mild-to-moderate Alzheimer's disease, is an antibody that targets beta-amyloid (A?), a protein that can exert toxic effects in the brain and is believed to play a central role in the pathology of Alzheimer's disease.
Alzheimer's disease, the most common form of dementia, is a degenerative brain disease that is not a normal part of aging.
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