Results From Preclinical Research & Phase Ib Study of Biogen’s Investigational Alzheimer’s Disease Treatment Published

Results from preclinical research and PRIME, the Phase Ib study of Biogen’s investigational treatment for early Alzheimer’s disease (AD), aducanumab, were published in a recent issue of Nature. The full manuscript is titled The Antibody Aducanumab Reduces Aβ Plaques in Alzheimer’s Disease and can be found at: http://www.nature.com/nature/journal/v537/n7618/full/nature19323.html.

The preclinical animal model and Phase Ib placebo-controlled study in prodromal and mild AD patients (n=165), both demonstrate 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 is hypothesized that removing it may slow the clinical decline of people who have AD.

“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.“Publication in Nature is an achievement we share with the many scientists and clinical investigators who conducted this research as well as the patients who volunteered to participate in our clinical trial; we are grateful to all of them.”

In addition to the results observed on amyloid plaque reduction, exploratory results from the Phase Ib study also 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. In the Phase Ib study, aducanumab demonstrated acceptable safety and tolerability profiles. The most frequently reported treatment-related serious adverse event (SAE) and adverse event (AE) was ARIA (amyloid-related imaging abnormalities).

The preclinical research included in this manuscript was first presented at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in Florence, Italy, March 2013. The Phase Ib data were first presented at AD/PD in Nice, France, March 2015.

Aducanumab is currently being evaluated by Biogen in two global Phase III studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease. For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov (NCT02477800 or NCT02484547).

Aducanumab (BIIB037) is an investigational compound being developed for the treatment of early Alzheimer’s disease. 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.
Aducanumab is thought to target aggregated forms of amyloid-beta, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on preclinical and interim Phase Ib data, treatment with aducanumab has been shown to reduce amyloid plaque levels.

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