Pfizer has revealed that its experimental Alzheimer’s drug bapineuzumab has failed one of four late-stage trials.
The trial involved patients carrying a variation of the ApoE4 gene that increases the chance of them developing the disease, however the trial failed to prove the treatment as effective as the drug failed to improve cognitive and life function in comparison with patients taking placebos.
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Concerns were also raised about a serious side effect related to bapineuzumab in edema, or swelling in the brain, that was uncovered through magnetic resonance imaging. The same side effect was originally detected during mid-stage trials and resulted in patients receiving smaller doses of the drug in further trials.
The trial was supervised by Johnson & Johnson, which is due to head a further phase three trial of bapineuzumab in patients who do not carry the ApoE4 gene variation, whereas Pfizer will continue with two further phase three trials of the drug involving both those with and without the ApoE4 gene.
Bapineuzumab is an injectable monoclonal antibody that works by attacking the beta-amyloid protein, thought to be a leading cause of Alzheimer’s disease.
Despite the disappointing trial results, it is hoped that the drug could prove to include secondary benefits including delaying the loss of memory in patients suffering from the illness, a benefit which could see the drug earn blockbuster status.
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By GlobalDataJohnson & Johnson expressed its disappointment at the results in a company statement, but remained upbeat about the potential of the drug, adding, "While we are disappointed in the results of this first study, the phase two (mid-stage) trials suggested that ApoE4 non-carriers may have a better chance of benefitting from bapineuzumab than ApoE4 carriers."
Data collected from the trial, as well as the companion study of ApoE4 non-carriers, will be presented at a European Federation of Neurological Societies meeting in September.
