Elan Corporation, plc and Wyeth Pharmaceuticals, have begun the North American phase III clinical trial for bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease.
The phase III clinical programme for bapineuzumab is intended to provide safety and efficacy data to support the filing and approval of licensing applications for bapineuzumab as a potential treatment for patients with mild to moderate Alzheimer's disease.
The phase III trial for bapineuzumab is the first known late-stage investigation to date of an antibody to potentially treat Alzheimer's disease. It will include four randomised, double-blind, placebo-controlled studies in approximately 4,000 total patients with mild to moderate Alzheimer's disease. More than 350 sites worldwide are expected to participate in the programme. Patients are planned to be distributed equally between NA and the rest of the world (ROW). The NA studies now are under way. The ROW studies are expected to begin enrolling patients in early 2008.
Each of the four studies will have co-primary efficacy endpoints one cognitive and one functional and patients are planned to participate for 18 months and will be evaluated using several methods, including neuropsychiatric scales and imaging and biomarker analysis.
Bapineuzumab (AAB-001) is a humanised monoclonal antibody that received fast track designation from the US Food and Drug Administration (FDA) for the potential treatment of mild to moderate Alzheimer's disease. Fast track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.
There are two ongoing phase II studies with bapineuzumab. No conclusion about the phase II studies can be drawn until the studies have been completed and the final data are analysed and released beginning around mid-2008.
Alzheimer's disease is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As Alzheimer's disease progresses, individuals may also experience changes in personality and behaviour, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It currently is estimated that more than 5 million Americans have Alzheimer's disease, and more than 24 million people worldwide age 60 and older have some form of dementia.
The Elan and Wyeth Alzheimer's Immunotherapy Programme (AIP) includes investigational clinical programmes for bapineuzumab (AAB-001), bapineuzumab SubQ, ACC-001 and AAB-002. AIP is a 50:50 collaboration to research, develop and commercialise an immunotherapeutic approach that may be used for the treatment of mild to moderate Alzheimer's disease and possibly to prevent the onset of the disease.
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.