Eli Lilly has announced a promising drug that would have become the first disease-modifying treatment for Alzheimer’s disease has failed a late-stage clinical trial.
The results come as a devastating blow for Indianapolis-based Lilly, which had sunk decades of research and hundreds of thousands of dollars into the medication, called solanezumab, or “sola.”
The pharmaceutical world had held its breath awaiting the results of the final-stage study, which were expected to be released in early December.
However, early Wednesday the company announced patients with mild dementia from Alzheimer’s treated with the drug didn’t experience any slower cognitive decline compared to patients who took a placebo.
The drug was designed to fight the formation of amyloid plaques—buildups of certain proteins in the brain that scientists have posited may be behind the symptoms of Alzheimer’s.
The drug’s failure in patients with even mild forms of dementia now throws the so-called amyloid hypothesis into further question.
Still, in a press conference, Lilly neurologist Eric Seimers said the scientific community shouldn’t jump to conclusions.
“Generally it’s safe to say that you can’t disprove a hypothesis based on one single study, particularly one study in just people with mild dementia,” Seimers said.
Solanezumab had failed two earlier late-stage trials, but results of those studies indicated the drug might be effective in preventing cognitive decline in a smaller subgroup—patients with milder forms of Alzheimer’s.
Incoming Lilly CEO David Ricks said during a teleconference the company was disappointed but not discouraged.
“I think today’s news is a sober reminder that you have to do the studies,” said Ricks. “It’s hard, and it’s expensive, but ultimately when you succeed. It’s why it’s worth it."
Alzheimer’s disease affects close to 5-million Americans.