Biogen plans Phase 3 development of Alzheimer’s tau therapy diranersen after Phase 2 data
BIIB•Phase 2 CELIA misses primary endpoint, but shows biomarker and dose signals
Biogen plans to advance investigational tau-targeting ASO diranersen into confirmatory Phase 3 trials in early Alzheimer’s disease.
Phase 2 CELIA missed its primary endpoint on dose response in CDR-SB at 18 months, with no added benefit at higher doses.
60 mg every six months showed the strongest signal vs placebo: 26% less decline on CDR-SB, 42% on ADAS-Cog13, 50% on MMSE.
Biomarkers showed mean CSF total tau reductions of 50%-65%; tau PET also declined across evaluated brain regions.
Safety profile was generally tolerable; most common events were procedural pain, post-lumbar puncture syndrome, confusional state.
