Lilly’s Alzheimer’s disease drug fails in final-stage trial

Eli Lilly & Co.’s experimental Alzheimer’s treatment failed to slow the progression of the neurodegenerative disease, yet another setback to drugmakers and researchers who continue to seek a way to treat one of the most feared ailments in the world.

Patients treated with solanezumab didn’t show a meaningful slowing of cognitive decline compared with those who got a placebo, Lilly said in a statement Wednesday. The drugmaker said it hasn’t decided what next steps, if any, to take with the medicine.

The results of the trial “were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment,” said John Lechleiter, Lilly’s outgoing CEO. “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.”

The findings are the latest setback in the quest to find a treatment for Alzheimer’s disease, which affects more than 5 million Americans and 40 million people worldwide. More than 100 compounds have failed to show they could slow the condition that robs patients of their minds and eventually their ability to care for themselves.

Lilly will take a $150 million pretax charge, or about 9 cents a share after tax, related to the trial. It plans to announce 2017 guidance on Dec. 15. The company said it’s still committed to Alzheimer’s, and that it has other compounds it is studying.

Results from the large, final-stage clinical trial showed that patients with mild Alzheimer’s who took solanezumab didn’t respond better than patients given a placebo on tests of memory and mental function, the Indianapolis-based company said. The drug is designed to latch onto and isolate soluble forms of beta amyloid, the protein that experts believe turns toxic when it forms into clumps between the brain’s synapses.

Lilly said that other measures in the trial “directionally favored” the drug compared to placebo, but the differences were small. More data from the trial will be presented next month at a medical meeting in San Diego.

Those details may give investors new insight into Biogen’s biggest bet – expensive trials testing its own experimental Alzheimer’s drug, aducanumab. Like solanezumab, Biogen’s drug targets beta amyloid. An early study in 2014 showed that the drug reduced the protein in the brain and slowed cognitive decline, though later data raised questions about the relationship between the amount of drug taken and its effects. Merck & Co. also has a trial of its experimental drug verubecestat that blocks amyloid through a different mechanism.

The dementia-causing disease has grown into the sixth-biggest cause of death in the U.S., killing about 700,000 people annually, and is the only fatal condition among the top 10 in the U.S. that cannot be prevented, cured or slowed, according to the Alzheimer’s Association.

Companies have spent billions developing amyloid-blocking drugs with nothing to show for it. In recent years, researchers have switched directions, targeting a protein called tau that spreads through the brain as Alzheimer’s progresses, accumulating in tangles that choke the brain cells.

“We think the amyloid hypothesis should continue to be studied,” incoming CEO David Ricks said during an interview with CNBC on Wednesday.

Lilly has spent three decades developing treatments for Alzheimer’s disease, persisting in its efforts even as numerous attempts failed. The potential payoff for a medicine that actually slows the progression of the disease, keeping patients out of nursing homes and with their mental abilities intact, is massive. Available medicines, which ease symptoms of the disease and generally work for about six months, generate combined annual sales of about $3 billion.