Aducanumab: Updated Phase Ib data

Updated data from 166 patients with prodromal or mild AD in the double-blind, dose-escalation, U.S. Phase Ib PRIME trial showed that 3, 6 and 10 mg/kg IV aducanumab significantly reduced mean levels of amyloid plaque, as measured by florbetapir PET imaging using a composite standardized uptake value ratio (SUVR) of 6 regions of the brain, by 0.135, 0.21 and 0.268 from baseline to week 54 vs. almost no change for placebo (p<0.0001 for all). The 1 mg/kg dose of aducanumab led to a non-significant reduction in amyloid plaque of 0.055 vs. almost no change for placebo. On exploratory endpoints, 3 and 10 mg/kg aducanumab led to significantly slower cognitive declines, as measured by smaller reductions in Mini-Mental State Examination (MMSE) scores, at week 52 vs. placebo (0.7 and 0.56 points, respectively, vs. 2.81 points, p<0.05 for both). The 1 and 6 mg/kg doses of aducanumab led to non-significant reductions in MMSE scores of 2.18 and 1.96 points, respectively, vs. placebo. ...