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news.The Janssen AI and Pfizer Joint Steering Committee for the Alzheimer's Immunotherapy Program (AIP) has decided to discontinue all bapineuzumab intravenous (IV) studies in patients with mild-to-moderate Alzheimer's disease, based on the topline results of Study 301 along with a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype (Study 302).
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The co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in Study 301, aPhase 3 trial of IV bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype.
The Study 301 was led by Janssen Alzheimer Immunotherapy (Janssen AI) under Alzheimer’s Immunotherapy Program (AIP) in which Janssen AI and Pfizer are partners.
Pfizer global primary care business unit medicines development group head, senior vice president Steven Romano said the outcomes of the trial are disappointing.
"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," Romano added.
The discontinued studies include all follow-on extension studies in patients with mild-to-moderate Alzheimer’s disease receiving bapineuzumab IV in addition to Pfizer-led, Phase 3 studies (Study 3000 and Study 3001).
All patients in the discontinued studies will have a follow-up evaluation and the Alliance will conduct final data analyses, according to Pfizer.