Elan and Wyeth begin phase III bapineuzumab trial

Elan and Wyeth Pharmaceuticals have announced the dosing of the first patient in the phase III clinical study of bapineuzumab (AAB-001) as a treatment for patients with mild to moderate forms of Alzheimer’s disease.

The companies noted that the aim of this trial is to provide evidence of the safety and efficacy of the compound for this indication prior to an application for marketing authorisation for the drug with regulatory authorities.

Bapineuzumab is a humanised monoclonal antibody that has been designated as a fast-track compound by the US Food and Drug Administration – a status bestowed upon drugs that could potentially address an unmet need for serious conditions.

In total, around 4,000 patients with mild to moderate Alzheimer’s disease will be involved in the trial, that will encompass four randomised double-blind placebo-controlled studies at over 350 sites worldwide.

“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,” the companies report.

These methods will include biomarker analysis and the use of neuropsychiatric scales and imaging.

In May 2007, Elan reported that the decision to initiate a phase III trial of bapineuzumab was informed by the knowledge gleaned by the firms from their immunotherapy programmes.