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Elan Corporation and Wyeth Pharmaceuticals have started the first phase III trials of bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer’s disease.
The programme hopes to provide safety and efficacy data to support the filing and approval of licensing applications for bapineuzumab as a potential treatment for patients with the condition.
The phase III trial is the first late-stage investigation to date of an antibody to potentially treat Alzheimer’s disease.
It will include four randomised, double-blind, placebo-controlled studies across 350 sites in approximately 4,000 patients with mild to moderate forms of Alzheimer’s.
Patients will be distributed equally between North America and the rest of the world, and while the US studies have already started, the others are set to begin early next year.
Each of the four studies will have coprimary efficacy endpoints, one cognitive and one functional, and patients will participate for 18 months and be evaluated using several methods, including neuropsychiatric scales and biomarker analysis.
Bapineuzumab is a humanised monoclonal antibody that has received fast track designation from the US Food and Drug Administration (FDA).
This allows drugs that may substantially help serious or life-threatening conditions to move through the regulatory framework faster than normal.
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