Biogen (BIIB) and Eisai announced Tuesday that new data presented at the Clinical Trials on Alzheimer's Disease 2025 conference showed LEQEMBI produced measurable changes in levels of A-beta protofibrils in cerebrospinal fluid in a Phase 3 sub-study, Eisai said Tuesday.
In the 410-patient cohort, Eisai said total protofibril levels increased more in the LEQEMBI group than in placebo at 12 and 18 months, with a statistically significant difference at 12 months. Eisai and Biogen said the results confirm that LEQEMBI binding to protofibrils can be measured in cerebrospinal fluid.
Eisai said correlations seen in the placebo group between protofibril changes and several neurodegeneration and tau biomarkers were not observed with LEQEMBI treatment.
Eisai leads development and regulatory submissions for LEQEMBI globally, and the companies co-commercialize the drug.
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