Bapineuzumab: Phase III data

The double-blind, North American Phase III Study 302 trial in about 1,100 patients with mild to moderate AD who are carriers of the apolipoprotein E epsilon 4 (APOE4) genotype showed that IV bapineuzumab missed the co-primary endpoints of improving cognition as measured by ADAS-Cog scores and function as measured by DAD scores from baseline to 18 months vs. placebo. The most common adverse events associated with bapineuzumab were ARIA-E (amyloid-related imaging abnormalities-edema or effusion) and dehydration. Based on the data, the partners will stop bapineuzumab dosing in patients from Study 302 who enrolled in a follow-on extension trial.

Based on a review of the data by an independent safety monitoring committee, the partners said they will continue all other bapineuzumab trials as planned and without modifications. Study 302 is the first of 4 Phase III trials evaluating IV bapineuzumab. Two of the remaining 4 trials are evaluating the compound in AD patients who are non-carriers of the APOE4 genotype, which has been associated with an increased risk of late-onset AD. Pfizer and Johnson & Johnson are now looking ahead to Phase III data in non-carriers of the APOE4 genotype, a subgroup of patients that performed better than carriers in Phase II testing of bapineuzumab. The partners said they will present data from Study 302, as well as data from the Phase III Study 301 trial in about 1,300 AD patients who are non-carriers of the APOE4 genotype, at the European Federation of Neurological Societies meeting in Stockholm in September. Studies 301 and 302 are being conducted by J&J. ...