Eli Lilly and Co. (LLY) said that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase 3 TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in patients with early symptomatic Alzheimer's disease treated with amyloid-targeting therapies.
The study results were shared at the 15th Clinical Trials on Alzheimer's Disease conference. Donanemab is an investigational antibody that targets a modified form of beta amyloid plaque called N3pG.
The FDA has recognized that the reduction of amyloid beta plaque is a biomarker reasonably likely to predict clinical benefit in the treatment of early Alzheimer's disease.
In the co-primary outcomes, brain amyloid plaque clearance was achieved in 37.9% of donanemab-treated participants compared with 1.6% of Aduhelm-treated patients at 6 months. In the intermediate tau subpopulation, 38.5% of donanemab-treated participants reached brain amyloid clearance compared with 3.8% of Aduhelm-treated participants by 6 months.
In a key secondary outcome, donanemab reduced brain amyloid levels vs. baseline by 65.2% compared with 17.0% for Aduhelm at 6 months.
In an exploratory outcome, donanemab, but not aducanumab-avwa, treatment significantly reduced plasma P-tau217 at 6 months compared to baseline.
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