- Biogen and Eisai are stopping the global phase 3 ENGAGE and EMERGE trials of aducanumab in early Alzheimer’s disease on grounds of futility.
Why this matters
- There is unmet need for efficacious, safe treatments to slow or halt Alzheimer’s disease.
- Aducanumab, a monoclonal antibody that targets aggregated amyloid-β (Aβ), helps clear Aβ plaques from the brain and reduces calcium overload in murine models of Alzheimer’s disease.
- In 2016, US Food and Drug Administration granted Fast Track designation for the development of aducanumab.
- ENGAGE trial and EMERGE trial are phase 3 randomized, double-blind, placebo-controlled trials assessing efficacy and safety of monthly aducanumab vs placebo among a planned 3210 total patients with mild Alzheimer’s disease dementia.
- Main outcome for both is Clinical Dementia Rating–Sum of Boxes (CDR-SB) score.
- Futility analysis conducted by an independent data monitoring committee indicated the trials were unlikely to meet their primary endpoint on completion.
- Long-term extension of PRIME phase1b trial in prodromal or mild Alzheimer’s disease and EVOLVE phase 2 safety trial in mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia also being discontinued.
- Biogen and Eisai are considering initiation of planned phase 3 trial of aducanumab for secondary prevention.