Pfizer, J&J discontinue IV bapineuzumab

Pfizer Inc. (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) discontinued development of IV bapineuzumab after it missed the co-primary endpoints in the Phase III Study 301 trial in Alzheimer's disease patients who are non-carriers of the apolipoprotein E epsilon 4 (APOE4) genotype. The mAb against beta amyloid did not significantly improve cognition as measured by AD Assessment Scale-Cognitive subscale (ADAS-Cog) scores and function as measured by Disability Assessment for Dementia (DAD) from baseline to 18 months vs. placebo.

Study 301 was the second of four now-discontinued Phase III trials of IV bapineuzumab. Last month, the product missed the same endpoints in a trial in APOE4 carriers, a group of patients that had performed worse than non-carriers in Phase II testing (see BioCentury, July 24). ...