Lilly’s Donanemab Slows Cognitive, Functional Decline in Phase III Alzheimer’s Study
BIOMARKER
1. Eli Lilly's experimental drug, donanemab, has been shown to significantly slow cognitive and functional decline in early symptomatic Alzheimer’s disease patients in a Phase III study.
2. Following these results, Lilly aims to engage with regulatory bodies "as quickly as possible" for FDA submission.
3. Donanemab slowed cognitive and functional deterioration by 35% in Alzheimer’s disease patients with intermediate levels of the tau protein.
4. The integrated Alzheimer's Disease Rating Scale (iADRS), developed by Lilly, was used to measure decline in the study.
5. The iADRS assesses patients' ability to perform key daily tasks, such as driving, conversing, and managing finances.
6. The study also used the Clinical Dementia Rating-Sum of Boxes (CDR-SB) tool, showing donanemab slowed deterioration by 37% in the intermediate-tau group.
7. Donanemab significantly reduced amyloid plaque levels in the brain within six months of treatment initiation.
8. Some side effects were observed, including amyloid-related imaging abnormalities (ARIA), which were mostly mild to moderate and resolved with treatment.
9. Two patient deaths were attributed to ARIA, with a third fatality occurring after a serious ARIA episode.
10. Lilly's results put it in competition with Biogen and Eisai, whose Alzheimer's treatment, Leqembi, received accelerated FDA approval in January.