Biogen announced topline results from the Phase 2 CELIA study of diranersen (BIIB080) in patients with early Alzheimer's disease. The study did not meet its primary endpoint assessing dose response, but based on the strength of biomarker and efficacy data, Biogen plans to advance diranersen to registrational development.
Robust reductions in tau pathology were observed across all dose groups, as measured by PET imaging. Tau is a key protein associated with Alzheimer's disease progression. The study also showed a cognitive benefit in treated patients, marking the first time a tau-targeting therapy has demonstrated such effects in a clinical trial.
Diranersen is an antisense oligonucleotide designed to reduce the production of tau protein. The CELIA study enrolled patients with early Alzheimer's disease, including those with mild cognitive impairment and mild dementia due to Alzheimer's. Biogen is now preparing for a Phase 3 program to confirm these findings.
