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March 15, 2016 at 09:11 PM
(Bloomberg) — Eli Lilly & Co. (NYSE:LLY) has changed the primary goal of a test of its potential Alzheimer’s disease drug, an unusual move during an ongoing study, to focus solely on whether the treatment can forestall changes that may occur early in the course of the brain disorder.
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The final-stage clinical trial of solanezumab will mainly evaluate the drug’s impact on cognitive decline in patients, while removing measures of ability to perform activities of daily living, such as dressing and feeding oneself, Indianapolis-based Lilly said Tuesday in a statement. The study’s final patient was enrolled in the trial, called Expedition 3, in 2015, and the last patient visit will occur in October.
Lilly shares fell 3.8 percent to $71.15 at 2:06 p.m. in New York trading.
New research is showing that cognitive decline — the memory lapses and signs of forgetfulness that most people associate with dementia — develops relatively early in patients with Alzheimer’s disease. Functional impairment, where patients have trouble taking care of themselves in tasks like dressing and cooking, appears to come later, the company said.
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The modification may make it easier for the company to identify any benefit the medicine may be having, said Tim Anderson, an analyst at Sanford C. Bernstein & Co., in a note to clients. It also suggests Lilly is worried that there may not be a benefit in terms of better functioning for patients taking the experimental drug, he said.
‘Concerning’ move
“Regulatory agencies will likely require Alzheimer’s disease drugs to demonstrate both cognitive and functional changes to gain full approval, so on its surface this move by the company is concerning,” said Anderson, who has an outperform rating on Lilly shares. “However, as there is no firmly established regulatory pathway for disease-modifying Alzheimer’s disease drugs, our belief is that regulators will maintain flexibility.”
The study of solanezumab is the first drug trial to examine only patients with mild Alzheimer’s disease. Treatments like it are designed to slow progression of the disease, which often worsens over years or decades. Companies and researchers have started giving experimental treatments to patients earlier in hopes of stopping mental decline before the brain is too damaged to recover.
