Bapineuzumab is an experimental, humanized monoclonal antibody that binds to β-amyloid and is being studied as a potential therapy to delay the progression of Alzheimer’s disease in patients with mild to moderate cases of the condition. Alzheimer’s disease is a chronic neurodegenerative disorder that results in a progressive decline in cognitive functions including memory, decision-making and language and ultimately leads to death. Bapineuzumab has received fast-track designation from the USFDA, which means that it may receive expedited approval in certain circumstances, in recognition of its potential to address the significant unmet needs of patients with Alzheimer’s disease. The drug is being developed by Elan, Pfizer, and Johnson and Johnson.
How Bapineuzumab Works
Bapineuzumab binds to β-amyloid. It is designed to provide antibodies to β-amyloid directly to the patient and clear toxic β-amyloid. If β-amyloid plays an important role in the formation of the amyloid plaques seen in the brains of patients with Alzheimer’s disease, as is hypothesized, then bapineuzumab could be a potential treatment for this high unmet medical need.
The global bapineuzumab Phase 3 program was initiated in December 2007 and includes four randomized, double-blind, placebo-controlled studies. Two of these studies test bapineuzumab in carriers of the ApoE4 allele (one in North America; one internationally) and two studies test bapineuzumab in non-carriers (one in North America; one internationally). The two non-carrier trials were originally anticipated to enroll approximately 1,250 patients each. With the removal of the 2.0 mg/kg dose group, it is now expected that the studies will each have approximately 1,000 patients for efficacy evaluation. The two carrier trials, which only test the 0.5 mg/kg dose, are expected to enroll approximately 800 patients each.