Eli Lilly says donanemab met all primary, secondary endpoints in Phase 3 study

Eli Lilly and Company announced 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. These data comparing donanemab to Aduhelm to assess superiority on amyloid plaque reduction 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. Through the FDA’s accelerated approval pathway, 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. Through the FDA’s accelerated approval pathway, 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. "The purpose of this first ever active comparator trial of amyloid lowering agents was to answer important questions about potential differences in amyloid plaque reduction," said Mark Mintun, M.D., group vice president of pain and neurodegeneration research and development, Eli Lilly and Company. "These data reinforce our confidence in donanemab’s unique mechanism of action based on reductions in key biomarkers of Alzheimer’s disease, amyloid plaque and plasma phosphorylated tau (P-tau). Importantly, this was also the first study to obtain ARIA rates side by side using identical methods for ARIA assessment in the same patient population, demonstrating the ability to disconnect rate of plaque clearance from rate of ARIA incidence."