BioCentury
ARTICLE | Clinical News

Biogen's aducanumab shows continued improvements through 48 weeks in Phase Ib extension for Alzheimer’s

November 9, 2018 6:32 PM UTC

Biogen Inc. (NASDAQ:BIIB) reported additional data from the long-term extension of the Phase Ib PRIME trial to treat prodromal or mild Alzheimer’s disease showing that aducanumab (BIIB037) continued to reduce amyloid plaque levels through 48 months. The company also said analyses of exploratory clinical endpoints continued to suggest a slowing of cognitive decline through 48 months. Data were presented at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Barcelona.

Newly released data at 48 months showed that continuation of 3, 6 and 10 mg/kg aducanumab reduced mean levels of amyloid plaque, as measured by florbetapir PET imaging using a composite standardized uptake value ratio (SUVR) of six regions of the brain, from Phase Ib baseline by 0.261, 0.324 and 0.34, respectively. Those reductions corresponded to mean improvements in Clinical Dementia Rating Sum of Boxes (CDR-SB) scores of 5.57, 7.75 and 3.87 points, respectively, at 48 months. Mean Mini-Mental State Examination (MMSE) scores improved by 8.22, 12.62 and 4.82 points, respectively. There were no new cases of amyloid-related imaging abnormalities-edema (ARIA-E) reported since the last interim analysis...