Bapineuzumab fails phase III
26.07.2012 - Pfizer and Johnson & Johnson report that Bapineuzumab failed the first of four phase III trials.
The monoclonal antibody Bapineuzumab could not outperform a placebo in moderating symptoms of mild-to-moderate Alzheimer's disease. Expectations on an intravenous formulation of the drug to help a group of patients sharing the so called ApoE4 (apolipoprotein E epsilon 4) genotype could not be fulfilled. Pfizer did not release details of the study’s outcome, but a principal investigator in the trial, Reisa Sperling, told The New York Times that "there was absolutely no evidence at all of a clinical benefit of treatment on either of the primary measures." The antibody developed by the Irish company Elan and US company Pfizer is tested in a large-scale Alzheimer's Immunotherapy Program for its suitability for treating the most common form of dementia. Meanwhile Johnson & Johnson joined the team for a total of four clinical trials. 1100 patients participated in the trail, all of them carriers of the ApoE4 risk gene. It is possible that patients without this gene modification could gain more profit from the agent. A second study with this group will start in the following weeks, two others are still ongoing.
Bapineuzumab is the follow up agent of AN1792, a vaccine which also failed. AN1792 successfully stimulated the formation of antibodies against beta amyloid – 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 – in animal studies. But in 2002, a phase II trial had to be stopped because of safety issues. Aseptic meningoencephalitis and leukoencephalopathy were diagnosed in 6 percent of the participants. Nevertheless, some hints were given that the vaccine achieved an effect. The same effects were expected for Bapineuzumab, of course without the negative consequences.