Partners Pfizer and Janssen Alzheimer Immunotherapy (Janssen AI) have ditched the Alzheimer’s disease (AD) candidate bapineuzumab after two Phase III studies evaluating the amyloid β-targeting antibody failed to show any meaningful benefits in terms of patient cognition or function.
The latest of the two failed Janssen AI-led trials, study 301, evaluated intravenous bapineuzumab in 1,300 patients with mild-to-moderate AD who don’t carry the ApoE4 genotype. The firm had previously reported disappointing data from study 302, which enrolled 1,100 patients who were carriers of the ApoE4 genotype. The Phase III program for bapineuzumab also included two Pfizer-led trials, designated 3000 and 3001. All ongoing studies will now be discontinued, including follow-on extension studies in patients with mild-to-moderate AD.
While voicing their disappointment at the failure of the two Phase III trials, Janssen AI and Pfizer say the results, combined with ongoing subgroup and biomarker analyses, will provide valuable new data to aid in ongoing research. “We believe that the trial results will provide a rich dataset that will advance our understanding of this complex disease and inform future research in this field,” comments Husseini K. Manji, M.D., global therapeutic area head for neuroscience at Janssen Research & Development. “Studies with other compounds in earlier stages of development in the Alzheimer’s Immunotherapy Portfolio (AIP) are continuing, and future development strategies will be discussed jointly by the alliance partners.”
Janssen Alzheimer Immunotherapy is a subsidiary of Johnson & Johnson. The firm’s AIP program was acquired from Elan Pharmaceuticals in 2009, and is being developed in collaboration with Pfizer through an equal collaboration.