Lilly changes Alzheimer’s trial endpoint – shares fall
pharmafile | March 16, 2016 | News story | Research and Development | Alzheimer's disease, Eli Lilly, solanezumab
Shares in Eli Lilly fell more than 4% yesterday when it announced it was changing the primary endpoint of a closely-watched late-stage clinical trial in Alzheimer’s disease.
The company confirmed its Phase III clinical trial of amyloid-busting drug solanezumab in mild Alzheimer’s dementia patients will now have cognition alone as a primary endpoint, as opposed to cognition and function, as previously stated.
Lilly said it was making this change because emerging scientific evidence suggests that cognitive ability declines before and is predictive of functional decline in Alzheimer’s, particularly in earlier stages of the disease. Function will remain a secondary endpoint of the trial.
Cognitive ability represents aspects including a patient’s memory and reasoning skills, whereas function measures their ability to perform basic everyday tasks like walking or preparing a meal.
Lilly said the change to the goal of the trial would not affect the manner in which it is conducted, and the company added it would remain blind to study data until Q4 2016, confirming that it had not seen results that would motivate it to change the trial’s endpoint.
It is not the first time solanezumab has faced setbacks on its development journey. The drug, which targets amyloid beta, failed in two key Phase III trials in 2012, although follow-up data later revived the company’s hopes.
Alzheimer’s disease is notoriously difficult to develop successful drugs for; Pfizer and Johnson & Johnson’s bapineuzumab being another high profile failure.
Joel Levy
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