Eli Lilly's drug for Alzheimer's fails in trial

U.S. pharmaceutical giant Eli Lilly announced Wednesday that its highly anticipated experimental Alzheimer's drug called solanezumab has failed in a late-stage trial, dealing another blow to efforts to combat the illness.

"Solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase three study of solanezumab in (more than 2,100) people with mild dementia due to Alzheimer's disease," the company said in a statement.

Patients treated with the drug "did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo," it said.

Lilly also said it will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease.

"The results of the solanezumab EXPEDITION3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease," John Lechleiter, chairman, president and chief executive officer of Lilly, said in the statement.

"We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."

Solanezumab also failed in two previous phase three clinical trials, known as EXPEDITION 1 and 2, which involved patients with mild-to-moderate Alzheimer's disease.

"It's extremely disappointing to learn that it hasn't delivered a meaningful change for people living with dementia, when the need is clearly so great," Jeremy Hughes, chief executive of Alzheimer' s Society, said in a statement.

"Dementia is society's biggest health challenge -- and we've seen time and again that developing effective treatments is incredibly difficult. This is only one drug of several in the pipeline and they aim to tackle dementia in different ways, so we should not lose hope. Dementia can and will be beaten."

Professor Peter Roberts of University of Bristol, said he was not in the least surprised by the solanezemab data.

"The problem, to my mind, is completely fundamental," Roberts said. "There is still no convincing evidence that shows a clear relationship between amyloid deposition and deficits in cognition in humans. All we really know is that evidence of amyloid deposition begins up to maybe 20 years before the onset of Alzheimer's disease. This might be a good indicator, but does not prove causality."

Alzheimer's disease is a fatal illness that is believed to start with changes in the brain that may begin 20 years or more before symptoms appear. Those changes cause a progressive decline in memory and other aspects of cognition that eventually lead to dementia.

There are currently an estimated 47 million people living with dementia worldwide. The number of people affected by dementia is expected to reach nearly 75 million in 2030 and 131 million in 2050. Enditem