- Trial focused on cognitive decline will conclude this year
- Changes in activity levels a secondary endpoint in study
Eli Lilly & Co. 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.
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.
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.
“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.
The change in the study’s goal won’t affect how it’s conducted or give researchers any hint of which patients are getting the medicine, either of which would compromise the integrity of the results, according to the statement. The major difference lies in how the results will be analyzed and interpreted, Lilly said.
The functional changes, which now are often considered simultaneously with measures of cognition, still will be evaluated as a secondary measure in the trial, the company said.
Alzheimer’s disease is the most common form of dementia, a condition affecting 5.3 million Americans that is marked by progressive memory loss and difficulty in caring for oneself, according to the Alzheimer’s Association. There are no therapies currently available to slow the inexorable decline linked to the disease, though treatment can temporarily improve symptoms.
If Lilly’s solanezumab proves effective, it would be the first so-called disease modifying treatment for Alzheimer’s. Such a finding could double the company’s stock price, Anderson said. Conversely, the shares could plunge 15 percent if the study fails to show a benefit, he said. He currently gives the drug a 30 percent to 40 percent chance of success, a self-acknowledged “best guess.”