Eli Lilly and Co. announced Wednesday that an experimental drug that slows the progression of cognitive decline in healthy older adults at high risk of Alzheimer’s disease has failed.
The Indianapolis-based pharmaceutical company says that treating patients with a drug called solanezumab over a 4.5-year course of treatment does more than placebo to clear sticky plaques called amyloid from the brain that are often associated with the disease. The drug did not stop plaque buildup.
The results represent another disappointment for both Lilly and the experimental drug, in that a large clinical trial in 2016 failed to slow the progression of Alzheimer’s disease in people already suffering from cognitive decline. rice field.
The trial enrolled more than 1,100 people between the ages of 65 and 85 who had masses of amyloid plaque buildup in their brains and had no clinical deficits such as cognitive decline or memory loss. This study tested whether solanezumab could slow the progression of Alzheimer’s disease-related cognitive decline, brain imaging, and other biomarkers.
“Solanezumab had no substantial effect on amyloid plaque load in the brain and unfortunately did not slow cognitive decline,” said Reisa, a neurologist and project director at Brigham and Women’s Hospital, Harvard Medical School. Dr. Sperling said. “These data suggest that a more aggressive approach to amyloid clearance may be needed, even in the very early stages of the disease.”
The study appears to have closed the door on solanezumab’s clinical development and one of the hottest experimental drugs of the past decade, Lilly said. was seen as a potential game-changer for treating
John Sims, Head of Medical Global Brand Development for Lilly’s solanezumab, said:
Lilly has spent more than $3 billion over the past 30 years to find a cure for the disease, the sixth leading cause of death in the United States.
The future remains uncertain about the company’s development of other potential treatments for Alzheimer’s disease. In January, federal regulators denied Lilly’s application for early approval of another potential treatment called donanemab.
For two years, Lilly has touted donanemab as a potential breakthrough in treating Alzheimer’s disease, saying the drug, given monthly, can target and remove large amounts of amyloid plaques from the brain.
Still, the Food and Drug Administration said it would like to see data from at least 100 patients who received at least 12 months of continuous treatment with the experimental drug. said that this meant that they were able to discontinue the medication as early as 6 months of treatment.
The solanezumab study was a public-private partnership and was funded by Lilly, the National Institute on Aging, the Alzheimer’s Association, the GHR Foundation, the Foundation for the National Institutes of Health, and several other organizations and donors.
