Eli Lilly Alzheimer’s Drug Shows Promise in Phase 3 Study
- Posted by ISPE Boston
- On May 18, 2023
Eli Lilly has announced positive results of its Phase 3 study, showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the FDA this quarter. Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals.
The 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 symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) and the mild dementia stage of disease, with the confirmed presence of AD neuropathology.
“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,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. “This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”
In addition to slowing cognitive and functional decline, donanemab produced significant reductions in brain amyloid plaque levels as early as 6 months after initiating treatment, as observed using amyloid positron emission tomography (PET) brain scan, with many patients reaching amyloid levels considered negative for pathology.
“Amyloid plaque is a defining pathophysiological feature of Alzheimer’s disease,” said Dr. Eric Reiman, CEO of Banner Research, one of the research sites for the trial. “This study’s topline results provide compelling support for the relationship between amyloid plaque removal and a clinical benefit in people with this disease.” (Source: Eli Lilly Website, 03 May, 2023)