Biogen Inc (NASDAQ:BIIB) announced results from an analysis of the long-term extension of its ongoing Phase 1b trial of aducanumab, the firm’s investigational therapy for early Alzheimer’s disease. The latest analyses comprise data from the placebo-controlled duration and LTE for subjects administered aducanumab up to 24-months in case of the titration cohort and up to 36-months in event of the fixed-dose cohorts. The data is consistent with previously announced analyses from this current Phase 1b trial and support the design of the underway Phase 3 trials of aducanumab for early Alzheimer’s.
The Phase Ib is a randomized, placebo-controlled, double-blind, multiple-dose trial assessing the safety, tolerability, pharmacodynamics (PD), pharmacokinetics (PK) and clinical effects of aducanumab in subjects with mild or prodromal Alzheimer’s disease. The trial comprises fixed dosing at 1, 3, 6 and ten mg/kg and an arm with a titration plan.
Subjects who are through the 54-week, placebo-controlled duration of the Phase Ib trial had the alternative to continue in the LTE. The new assessments comprise 143 subjects who stayed in the LTE.
In the Phase Ib LTE, the most commonly recorded adverse events were fall, headache and amyloid-related imaging abnormalities. Of the 185 subjects dosed with aducanumab in the Phase Ib trial, 46 patients witnessed ARIA-E. There were no new instances of ARIA-E in people who continued on the same aducanumab dose.
The incidence of ARIA-E in subjects switching to aducanumab from placebo was consistent with the occurrence reported in the placebo-controlled part of the Phase Ib trial. Six patients witnessed more than 1 episode of ARIA-E. These repeated events were in-line with other ARIA events recorded to date; they were usually asymptomatic, and most subjects continued in the trial. Biogen intends to share more details from these analyses at an imminent medical congress.
Aducanumab is currently being assessed in two global Phase III trials, EMERGE and ENGAGE, which are intended to evaluate its efficacy and safety in slowing cognitive impairment and the evolution of disability in patients with early Alzheimer’s disease.