Boston-based biotech company Biogen had pre-clinical research and Phase 1b results for aducanumab, its investigational antibody treatment for early Alzheimer's disease, published in the Sept. 1, 2016 issue of Nature.
Information released by Biogen said the pre-clinical animal model and Phase 1b placebo-controlled study in prodromal and mild AD patients (n=165), both demonstrated aducanumab reduced amyloid-beta in the brain and that the reduction was dose-dependent. With the association of amyloid plaque and AD, the hypothesis is that removing the plaque could slow the clinical decline in AD patients. Exploratory results from the Phase 1b study demonstrated dose- and time-dependent slowing of clinical decline as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) scores.
"These early studies of aducanumab show its effectiveness in removing amyloid plaque from the brain, as well as its potential effect on the slowing of cognitive decline in patients suffering from Alzheimer's disease," said Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen.
Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune's technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.
In the Phase 1b study, aducanumab demonstrated acceptable safety and tolerability profiles. The most frequently reported treatment-related serious adverse event and adverse event was ARIA (amyloid-related imaging abnormalities). Two larger Phase 3 trials are currently underway.