Pfizer and Janssen AI, partners in the Alzheimer’s Immunotherapy Program (AIP), released the co-primary clinical endpoints in the Janssen AIP Phase III trial of intravenous bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype. The change in cognitive and functional performance compared to placebo, were not met, and the Janssen AI and Pfizer Joint Steering Committee for the AIP has discontinued all other bapineuzumab IV studies in patients with mild-to-moderate Alzheimer’s disease.
“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.”
Pfizer plans to continue Phase II development of a subcutaneous formulation of the therapy.