Eli Lilly’s experimental Alzheimer’s drug has been shown to significantly slow cognitive and functional decline in patients with early symptomatic disease, according to phase 3 results presented at this year’s Alzheimer’s Association International Conference (AAIC).
The drug, donanemab, is an intravenous antibody designed to remove deposits of a protein called beta amyloid from the brains of Alzheimer’s disease patients.
The late-stage TRAILBLAZER-ALZ 2 study has been evaluating the candidate in more than 1,700 patients with early symptomatic Alzheimer’s disease who were grouped by their level of the tau protein, a predictive biomarker for disease progression.
Lilly has previously announced that the trial met its primary endpoint, with the drug slowing the progression of the disease by 35% using the iADRS scale and 36% using the CDR-SB scale in 1,182 patients with early symptomatic Alzheimer’s and low-medium levels of tau.
All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said.
The full results from TRAILBLAZER-ALZ 2, presented at AAIC, reinforce the cognitive and functional benefits of donanemab treatment regardless of baseline clinical or pathological stage of disease.
A pre-specified subpopulation analysis of low-medium tau participants showed the drug works best in those at an earlier stage of disease. In participants with mild cognitive impairment, donanemab slowed decline by 60% on iADRS and 46% on CDR-SB.
The new data also showed that the overall treatment effect of donanemab continued to increase compared to placebo throughout the trial, with the greatest difference seen at 18 months.
Lilly said it expects the US Food and Drug Administration to decide by the end of this year whether to approve donanemab, adding that submissions to other global regulators are underway.
Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said: “The positive TRAILBLAZER-ALZ 2 data bring hope to people with Alzheimer’s disease who urgently need new treatment options. This is the first phase 3 study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study.”
“We must continue to remove any barriers in access to amyloid-targeting therapies and diagnostics in an already complex healthcare ecosystem for Alzheimer’s disease,” White added.