An experimental Alzheimer’s drug being developed by Eli Lilly failed to slow cognitive decline in over 2,100 patients with mild dementia as a result of Alzheimer’s participating in a phase 3 study.
It failed to produce any statistically significant results in preventing mental decline compared to the placebo group. No new safety signals emerged in the study either.
“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,” said Eli Lilly’s chairman, president and CEO John C. Lechleiter in a statement.
Lilly won’t pursue any regulatory submissions for solanezumab for this specific indication, but this news casts doubts on the viability of developing Alzheimer’s drugs that target amyloid-beta plaques, which are believed to be an underlying cause of this disease.
Previous studies of these drugs had failed to show benefits in patients with established Alzheimer’s related dementia so clinicians proposed administering these drugs at an earlier stage in the disease in order to unlock its efficacy.
Yet, this failure could add credence to the theory that, “amyloid deposits are a trigger for other pathologies in the brain and become irrelevant once those mechanisms come into play,” according to FierceBiotech.
The company isn’t completely giving up on solanezumab. Another study is currently underway where investigators are analyzing the drug’s impact on people who have the beta amyloid plaques with no symptoms of Alzheimer’s, wrote Reuters.
Solanezumab could generate up to $10 billion in annual sales if approved, but Lilly said it would still take $150 million charge in the fourth quarter and will update its financial outlook for 2016 on December 15 and provide a forecast for next year.
Investigators in charge of the EXPEDITION study will present the results at the annual Clinical Trials on Alzheimer’s disease meeting on December 8th.
Filed Under: Drug Discovery