Last week Eli Lilly and Company announced that nearly half of the participants on their early Alzheimer’s drug donanemab had no clinical progression at 1 year. The study showed donanemab treatment slowed clinical decline by 35% compared to placebo and resulted in 40% less decline in the ability to perform activities of daily living. Based on these results, Lilly will proceed with making a submission to the U.S. Food and Drug Administration later this quarter.
TRAILBLAZER-ALZ 2, a randomized, double-blind, placebo-controlled study, evaluated the safety and efficacy of donanemab, an investigational amyloid plaque targeting therapy. The study enrolled people with early Alzheimer’s disease. This includes mild cognitive impairment and the mild dementia stage of the disease. The participants completed their course of treatment with donanemab once they reached a prespecified level of amyloid plaque clearance.
Lily stated that additional prespecified secondary analyses showed:
• 47% of participants on donanemab showed no decline in CDR-SB, a key measure of disease severity at 1 year (compared to 29% of participants on placebo, p<0.001).
• 52% of participants completed their course of treatment by 1 year and 72% completed by 18 months as a result of achieving plaque clearance.
• Participants on donanemab had 40% less decline in the ability to perform activities of daily living at 18 months [as measured by Alzheimer’s Disease Cooperative Study – Instrumental Activities of Daily Living Inventory (ADCS-iADL), p<0.0001].
• Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo (CDR-Global Score, HR=0.61; p<0.001).
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories stated, “We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial. This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”