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Biogen Advances Tau-Targeting Alzheimer's Drug to Phase 3 Despite Mixed Phase 2 Results
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Biogen Advances Tau-Targeting Alzheimer's Drug to Phase 3 Despite Mixed Phase 2 Results

May 14, 2026

Biogen reported mixed Phase 2 results for diranersen (BIIB080) on May 14, 2026 and is advancing the tau-targeting Alzheimer's drug to Phase 3 studies. The trial reduced tau levels in spinal fluid and brains of early-stage patients, correlating with slowed cognitive decline, but failed to achieve its primary efficacy goal of a dose response. The lowest dose showed the best results among three escalating regimens tested.

Phase 2 trial results

  • ▪Adam Feuerstein is a senior writer and biotech columnist who reports on the crossroads of drug development, business, Wall Street, and biotechnology
  • ▪Diranersen targets the protein tau, which is toxic to neurons and is believed to play a role in cognitive decline in Alzheimer's patients
  • ▪Biogen investigated three escalating dosing regimens in the Phase 2 study of diranersen
  • ▪Biogen reported mixed results on May 14, 2026 from a Phase 2 clinical trial investigating diranersen (BIIB080) for Alzheimer's disease

Tau protein reduction

  • ▪Diranersen reduced levels of tau in the spinal fluid and brains of patients with early-stage Alzheimer's in the Phase 2 study
  • ▪Tau reductions from diranersen correlated to a slowing of cognitive decline in the Phase 2 study

Dose response failure

  • ▪The lowest dose of diranersen showed the best results in the Phase 2 study
  • ▪The Phase 2 study of diranersen failed to achieve its primary efficacy goal, which was a dose response

1 source

Statnews
STAT+: Biogen’s tau-targeting Alzheimer’s drug posts mixed results in mid-stage study
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Tau protein

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Alzheimer’s & dementiaDrug Approval and Clinical TrialsAlzheimer's diseasePharmaClinical trialsMental healthDrug development