Eli Lilly Drug for Alzheimer’s Shows Positive Phase 2 Results
- Posted by ISPE Boston
- On March 19, 2021
Phase 2 results presented today by Eli Lilly expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo. Additionally, data from secondary analyses showed donanemab consistently slowed cognitive and functional decline, with ranges between 20-40 percent in all secondary endpoints with nominal statistical significance at multiple times compared to placebo. Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer’s disease.
“We are confident in the results of the…study,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “This is the first late-stage study in Alzheimer’s disease to meet its primary endpoint at the primary analysis. Donanemab has the potential to become a very important treatment for Alzheimer’s disease. We were pleased to see not only slowing of cognitive and functional decline, but also very substantial clearance of amyloid plaques and slowing of spread of tau pathology. The constellation of clinical and biomarker results indicates the potential for long-term disease modification…” (Source: Eli Lilly Website, 13 March, 2021)