Drug news
Phase III development of bapineuzumab (Janssen Alzheimer Immunotherapy) in Alzheimer's disease discontinued
Janssen Alzheimer Immunotherapy has announced that its Phase III clinical development of bapineuzumab intravenous (IV) in mild-to-moderate Alzheimer's disease is being discontinued. This is based on the co-primary clinical endpoints not being met in the Janssen AI-led Studies 301 and 302. Four placebo-controlled Phase III studies comprised the bapineuzumab clinical development program. Janssen AI led the two completed 18-month, Phase III studies of patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301). In addition, Pfizer led two primarily ex-North America 18-month, Phase III studies of patients with mild-to-moderate Alzheimer's disease who are ApoE4 non-carriers (Study 3000) and carriers (Study 3001).