Pfizer said late Monday that the co-primary clinical endpoints were not met in the Phase III trial of an Alzheimer’s treatment being led by an entity of Johnson & Johnson’s Janssen Pharmaceuticals unit.
Janssen Alzheimer Immunotherapy (AI) R&D joined with Pfizer in setting change in cognitive performance and functional performance compared to placebo as the co-primary endpoints in Study 302, a Phase III 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 is the first of four placebo-controlled Phase III studies to reach completion in the comprehensive development program of bapineuzumab IV by Janssen AI and Pfizer, which are partners in the Alzheimer’s Immunotherapy Program (AIP). Janssen AI is leading two Phase III studies of patients who are ApoE4 carriers (Study 302) and noncarriers (Study 301) at sites primarily in North America. Also, Pfizer is conducting two Phase III studies of patients who are ApoE4 carriers (Study 3001) and noncarriers (Study 3000) at sites primarily outside of North America.
Studies 301, 3000, and 3001 are continuing “as planned and without modifications,” Pfizer said in a statement.
Topline results from Study 301 in patients with mild-to-moderate Alzheimer’s disease who do not carry ApoE4 are expected to be announced later this summer, Pfizer said, while the Pfizer-Janssen AI alliance will expedite completion of an interim analysis for Study 3001, based on the results of Study 302.
“While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer’s disease will be gained following the availability of additional data, including data from the soon-to-be available noncarrier Study 301,” Steven J. Romano, M.D., senior VP and head of the Medicines Development Group with Pfizer’s Global Primary Care Business Unit, said in the statement.