by
Thomas Dworetzky, Contributing Reporter | January 29, 2018
After earlier announcements of its failure in 2016, a paper in the New England Journal of Medicine confirms officially that Eli Lilly's monoclonal antibody-based drug solanezumab did not significantly slow cognitive decline in patients with Alzheimer's disease.
Columbia University Irving Medical Center (CUIMC) led the multicenter study of the agent, which targets amyloid plaques.
"Although we are disappointed that this particular drug did not prove successful, the field is benefiting from each study," said lead author Dr. Lawrence Honig, professor of neurology at CUIMC. "There is hope that one of the newer ongoing studies may result in an effective treatment for slowing the course of Alzheimer's disease.
“Clearly solanezumab at this dose in this population is not effective,”
Honig told Time, adding, “this study cemented that. But does this mean solanezumab might not be a good drug at a higher dose, a different population or both? No. It doesn’t imply that it might be effective at all. That’s being tested.”
Underlying the use of the drug is the hypothesis that Alzheimer's disease develops when there is a accumulation of a “sticky” protein – beta-amyloid. This protein then clumps into plaques in the brain that that lead to cell damage. Solanezumab was supposed to interfere with this process by lowering the amount of soluble amyloid molecules.
The study looked at over 2,000 patients with mild dementia from the disease in a double-blind, phase 3 trial.
Unfortunately, no statistically significant improvement on cognitive tests were found compared with placebo.
The study concluded that there might still be hope for the agent – advising that either an insufficient amount of drug was given, or that it was given too late in the disease course.
Solanezumab is still being tested in those at risk but without symptoms of Alzheimer's.
When news of the trial failure
first broke in late 2016, Eli Lilly reported that despite the failure to change the progression of the disease, the results “directionally favored solanezumab.”
The failure of the trial is not the end of the Eli Lilly Alzheimer's efforts, however. " Eli Lilly remains committed to Alzheimer's research as we have been for nearly 30 years, and our portfolio includes many other promising approaches," said Jan Lundberg, Ph.D., executive vice president of science and technology, and president of Eli Lilly Research Laboratories.
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