Lilly’s older Alzheimer’s drug fails to prevent disease in trial

Eli Lilly and Co. said Wednesday that an experimental drug failed to slow progression of cognitive decline in healthy elderly patients at high risk for Alzheimer’s disease, the latest setback for finding a treatment for a disease that ravages the brains of more than 5 million Americans.

The Indianapolis-based drugmaker said treating the patients with a drug called solanezumab over a 4.5-year course of treatment did not perform better than a placebo in clearing a sticky plaque called amyloid from the brain that is often associated with the disease. Nor did the drug halt accumulation of the plaque.

The results marked another disappointment for both Lilly and the experimental drug, which had failed in a large clinical trial in 2016 to slow the progression of Alzheimer’s disease in people already suffering from cognitive decline.

The trial enrolled more than 1,100 people between 65 and 85 years of age who had clumps of amyloid plaque accumulation in the brain but who did not yet have clinical impairment, such as cognitive decline or memory loss. The study tested whether solanezumab could slow the progression of Alzheimer’s disease-related cognitive decline, brain imaging, and other biomarkers.

“Solanezumab did not substantially impact amyloid plaque burden in the brain, and unfortunately did not slow cognitive decline,” said Dr. Reisa Sperling, a neurologist at the Brigham and Women’s Hospital, Harvard Medical School and the project director. “These data suggest that we may need to be more aggressive with amyloid removal even at this very early stage of disease.”

Lilly said the study concludes its clinical development of solanezumab, apparently shutting the door on one of the most closely watched experimental drugs over the past decade. For a time, the drug was regarded as a potential game-changer for treating the ravages of Alzheimer’s disease.

“While this study was negative, the unique data generated have increased our understanding of preclinical Alzheimer’s disease and will advance the next generation of AD prevention studies,” said John Sims, Lilly’s head of medical global brand development of solanezumab.

Lilly has spent more than $3 billion over the past three decades trying to find a treatment for a disease that is the sixth-leading cause of death in the United States.

The future remains unclear for the company’s development of other potential treatments for Alzheimer’s disease. In January, federal regulators rejected Lilly’s application for accelerated approval of another potential treatment called donanemab.

Lilly has been touting donanemab for two years as a potential breakthrough in treatment of Alzheimer’s disease and has said the drug, which is given monthly, can target and clear large amounts of amyloid plaque from the brain.

Yet, the Food and Drug Administration said it wanted to see data from at least 100 patients who received a minimum of 12 months of continued treatment on the experimental drug. Lilly had said the speed of the plaque reduction meant many patients were able to stop dosing as early as six months of treatment.

The solanezumab study was a public-private partnership, funded by Lilly, the National Institute on Aging, the Alzheimer’s Association, GHR Foundation, Foundation for the National Institutes of Health, and several other organizations and donors.