Results from preclinical research and from the phase 1b PRIME study of aducanumab (Biogen), an investigational treatment for patients with early Alzheimer’s disease (AD), have been published in the September 1 issue of Nature.
Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from healthy elderly subjects with no signs of cognitive impairment and from cognitively impaired elderly subjects with unusually slow cognitive decline. The treatment is thought to target aggregated forms of amyloid-beta, including soluble oligomers and insoluble fibrils, deposited into the amyloid plaque in the brains of AD patients.
The preclinical animal model and the phase 1b placebo-controlled study in 165 patients with prodromal or mild AD both demonstrated that aducanumab reduced amyloid-beta in the brain, and the reduction was dose dependent. Amyloid-beta plaque is associated with the development of AD, and it has been hypothesized that removing it may slow the clinical decline of patients with AD.
In addition to the observed effects on amyloid plaque reduction, exploratory results from the phase 1b study demonstrated dose- and time-dependent slowing of clinical decline, as measured by Clinical Dementia Rating-Sum of Boxes and Mini-Mental State Examination scores. In the phase 1b study, aducanumab demonstrated acceptable safety and tolerability profiles. The most frequently reported treatment-related adverse events were amyloid-related imaging abnormalities.
Biogen is currently evaluating aducanumab in two global phase 3 studies, ENGAGE and EMERGE, which are designed to determine its safety and efficacy in slowing cognitive impairment and the progression of disability in patients with early AD.
Source: Biogen; August 31, 2016.