Elan, Wyeth kick off North American leg of Phase 3 Program for bapineuzumab in Alzheimer’s Disease

DUBLIN—Elan Corp. and Wyeth Pharmaceuticals, a division of Wyeth, recently announced the first patient in North America has been dosed as part of a global Phase III clinical program—under a fast-track designation from the FDA—for bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease.

The Phase III clinical program 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 clinical program for bapineuzumab (AAB-001) is the first known late-stage investigation to date of an antibody to potentially treat Alzheimer's disease. It will include four randomized, 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 program. Patients are planned to be distributed equally between North America and the rest of the world. The studies in North America now are under way. The other studies are expected to begin enrolling patients during the first part of the year.

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.

The Elan and Wyeth Alzheimer's Immunotherapy Program (AIP) includes investigational clinical programs for bapineuzumab, bapineuzumab SubQ, ACC-001 and AAB-002. AIP is a 50/50 collaboration to research, develop and commercialize 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.