Clinical TrialMay 14, 2026, 07:00 AM
Biogen's Diranersen Phase 2 CELIA Study Shows Cognitive Benefit
AI Summary
Biogen announced compelling topline results from its Phase 2 CELIA study evaluating diranersen (BIIB080) for early Alzheimer's disease. The study demonstrated robust reductions in tau pathology and slowing of clinical decline across all studied doses, with particular benefit at the lowest dose. While the study did not meet its primary endpoint for dose response, the overall efficacy and biomarker results provide confidence to advance diranersen to registrational development. The safety and tolerability profile was consistent with previous studies.
Key Highlights
- Phase 2 CELIA study of diranersen (BIIB080) showed robust reductions in tau pathology across all doses.
- Pre-specified analyses demonstrated slowing of clinical decline across all studied doses.
- The lowest dose of diranersen (60 mg every 24 weeks) showed particular benefit in slowing clinical decline.
- The CELIA study did not meet its primary endpoint assessing dose response for change from baseline on CDR-SB at Week 76.
- The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study.
- Biogen plans to advance diranersen to registrational development.
- Diranersen received U.S. FDA Fast Track designation for Alzheimer's disease in 2025.
- Biogen obtained a worldwide, exclusive license for diranersen from Ionis Pharmaceuticals in December 2019.