Lilly’s Solanezumab Fails in Phase 3 Alzheimer’s Trial

Eli Lilly has also been running “prevention” trials to see whether solanezumab might be able to stop people at particularly high genetic risk of Alzheimer’s from getting the disease. More data from the trial will be presented next month at a medical meeting in San Diego. The company said solanezumab did not slow down patients’ mental decline compared to a placebo.

“As far back as”.

The main goal of the study was to test whether solanezumab slowed the decline in cognition versus a placebo.

“For Biogen and other companies in the Alzheimer’s field, this is a serious blow”, Leerink Partners analyst Seamus Fernandez said in a research note carrying the headline “Burnt Turkey for Biotech investors”.

The monoclonal antibody was trialled in 2100 patients diagnosed with early Alzheimer’s disease. The drug candidate was supposed to slow the rate of cognitive decline by reducing amyloid beta, which are protein fragments that clump together into plaques considered by many to be the root cause of the disease.

Biogen is racing to complete Phase III trials of aducanumab, which is created to clear beta amyloid that has already formed brain plaques.

Biogen (BIIB), down almost 6% today, also is working on an Alzheimer’s treatment; Merck (MRK) shares were down 1% in recent trading.

Along with the drug candidate, a number of prominent research theories were on trial. “Lilly never seemed to have a great answer for why they picked the solanezumab dose they did”.

“While (Lilly’s, Biogen’s and Merck’s) drugs all target the same protein, they all do it differently enough that there should not be much of a read-through from one drug to the other”, Anderson said in his note. However, other trials examining this agent are using different designs and outcomes, and so the results of those trials will be equally important, she said. United Technologies, which makes products including elevators and jet engines, added $1.20, or 1.1 percent, to $108.14 and construction and technical services company Jacobs Engineering Group climbed $1.47, or 2.5 percent, to $60.79.

The trial included more than 2,000 patients.

It is too soon to know whether targeting tau or other approaches will work. The Russell 2000 index of small-company stocks, which has risen for the previous 13 trading days, fell 0.5 per cent. This marks the third time Lilly’s treatment has missed the mark in a late-stage trial, and the company has abandoned any plans to submit it for Food and Drug Administration approval.

The company spent hundreds of millions on solanezumab, testing and retesting it on ever narrower populations of Alzheimer’s patients in hopes of seeing a benefit. There aren’t any drugs that effectively slow the disease’s progression, just ones that treat its symptoms.

On behalf of the millions of people living with Alzheimer’s disease and their families that we serve and represent, the Alzheimer’s Association is disappointed with the negative results of this clinical trial.

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

Researchers at Washington University in St Louis, Missouri, are also trialling solanezumab, and another similar antibody made by Roche, in people who are now healthy but genetically fated to develop Alzheimer’s.