Biogen Inc (NASDAQ:BIIB) reported data from a recently performed analysis of the LTE of its ongoing Phase 1b trial of aducanumab, the firm’s investigational therapy for early Alzheimer’s disease.
The revised assessments comprise results from the placebo-controlled period as well as LTE for subjects treated with aducanumab up to two years in the titration cohort and up to three years in the fixed-dose cohorts. The data is consistent with previously reported assessment from this ongoing Phase 1b trial and support the design of the current Phase 3 trials of aducanumab targeting early Alzheimer’s disease.
The Phase 1b is a randomized, placebo-controlled, double-blind, multiple-dose trial assessing the safety, tolerability, pharmacodynamics (PD), clinical effects and pharmacokinetics (PK) of aducanumab in people with mild or prodromal Alzheimer’s disease. The study comprises fixed dosing at 1, 3, 6 and 10 mg per kg and an arm with a titration plan.
Patients who passed the placebo-controlled period extending for 54-week of the Phase 1b trial had the alternative to continue in the LTE. Biogen reported that the new assessment comprise 143 subjects who were in the LTE. In the Phase 1b LTE, the commonly noted adverse events were fall, amyloid-related imaging abnormalities and headache.
Of the 185 subjects administered with aducanumab in the Phase 1b trial, 46 subjects witnessed ARIA-E. There were no new instances of ARIA-E in subjects who followed the same dose of aducanumab.
The occurrence of ARIA-E in subjects switching from placebo to aducanumab was steady with the incidence noted in the placebo-controlled part of the Phase 1b trial. Six patients faced over one episode of ARIA-E. These repeated events were steady with other ARIA events posted to date; they were usually asymptomatic, and most subjects continued in the study. Biogen plans to share additional results from these analyses at an approaching medical congress.