Clinical Trials
Eli Lilly has announced positive results from the TRAILBLAZER-ALZ 2 phase 3 trial assessing donanemab’s ability to slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
The drug met its primary endpoint of change from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS), measuring cognition and activities of daily living such as managing finances, driving, engaging in hobbies and conversing about current events. Additionally, all secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits.
Lilly is now expected to progress with global regulatory submissions as soon as possible, with plans to make a submission to the US Food and Drug Administration (FDA) by the end of the quarter (Q2 2023).
Analysis of the trial data showed that 47% of participants on the drug showed no decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at one year, compared to 29% on the placebo; 52% of participants completed their treatment in one year, while 72% completed in 18 months as a result of achieving plaque clearance; those treated with donanemab experienced 40% less decline in ability to perform daily activities at 18 months; and participants on donanemab also experienced at 39% lower risk of progressing to the next stage of disease compared to those in the placebo group.
Daniel Skovronsky MD PhD, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, commented: “Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer’s disease by elucidating basic mechanisms of AD pathology and discovering imaging and blood biomarker tools to track the pathology. 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.”