Biogen Reveals Positive Phase 2 Diranersen Data in Early Alzheimer's, Advancing to Phase 3

Biogen has unveiled full results from its Phase 2 CELIA trial showing that diranersen, a drug that targets tau protein in the brain, slowed Alzheimer's disease progression across all tested doses at 18 months, according to Montreal Gazette. The data were presented at the Alzheimer's Association International Conference (AAIC) 2026, one of the field's most watched scientific meetings.
Based on the results, Biogen says it plans to move forward with a confirmatory Phase 3 trial. The drug works as an antisense oligonucleotide, or ASO — a molecule designed to block the production of tau, a protein that builds up in the brains of people with Alzheimer's disease, Calgary Sun reported.
The CELIA trial tested diranersen in people with early Alzheimer's disease. The drug showed efficacy at every dose studied, according to Brantford Expositor. Researchers measured cognitive decline using the Clinical Dementia Rating Sum of Boxes, or CDR-SB — a standard scale that tracks how well patients think and function in daily life.
Results were consistent across multiple secondary endpoints, meaning the drug's benefits showed up in more than one way of measuring patient health. Biogen said the outcomes were "meaningful," suggesting real-world impact for patients — not just changes in lab numbers, The Observer noted.
Diranersen is an ASO therapy — a type of drug that uses short strands of synthetic DNA-like molecules to block a specific gene's instructions. In this case, it tells the brain's cells to stop making harmful tau protein. Northern News reported that the trial showed "robust" tau reduction in treated patients.
Tau tangles are one of two key hallmarks of Alzheimer's, alongside amyloid plaques. Most recent Alzheimer's drugs, including Biogen's own lecanemab, have focused on clearing amyloid. Diranersen takes a different approach by going after tau directly at the source — cutting off production rather than clearing the buildup, according to Mitchell Advocate.
The CELIA data are a significant moment for Biogen. The company faced major criticism in 2021 over the controversial approval of aducanumab and has worked to rebuild credibility in the Alzheimer's space. Moving diranersen into Phase 3 signals renewed confidence in its pipeline, Fort McMurray Today reported.
Phase 3 trials are larger and longer studies required before a drug can be approved for widespread use. If diranersen succeeds, it could become one of the first approved ASO therapies for Alzheimer's — a new class of treatment targeting tau rather than amyloid, according to Owen Sound Sun Times.
The CELIA trial focused on people with early Alzheimer's — a group where treatment is most likely to make a lasting difference. Catching the disease early gives drugs a better chance to slow damage before too much of the brain is affected. Pembroke Observer noted that the results build a case for targeting tau at the earliest stages of the disease.
Biogen has not yet announced a timeline for Phase 3 enrollment or a projected approval date. Still, the AAIC presentation marks a clear step forward. For the roughly 50 million people living with dementia worldwide, a new tau-targeting treatment could eventually offer an option beyond the amyloid-focused drugs now on the market, Fort Saskatchewan Record reported.
Publishers
11
Articles
10
Reach
11