Eli Lilly and Co. said Monday its experimental Alzheimer's drug led to a 34 per cent reduction in memory decline for patients with mild symptoms over a period of 18 months, giving it potential ammunition to seek approval for the medicine that showed no benefit in more advanced stages of the disease.
Shares of Eli Lilly rose as much as 5.6 per cent on Monday, to levels not seen since April 2008, as some investors were encouraged that the improvement could warrant consideration from the U.S. Food and Drug Administration.
Lilly in August said the drug, solanezumab, did not meet the primary goal of halting progression of the memory-robbing disease in patients with mild-to-moderate symptoms in two late-stage trials. But while many rival compounds have been relegated to the scrapheap after similar failures, Lilly indicated at the time that there were signs that solanezumab prevented cognitive decline for people at an earlier stage of the disease.
On Monday, the company presented results on the drug pooled from the two large studies that focused only on those with mild Alzheimer's.
"Today's data supports the view that solanezumab may be active in early Alzheimer's patients but that further clinical work will likely be needed prior to FDA approval of the product," said J.P. Morgan analyst Chris Schott, adding that any drug that slows Alzheimer's would have "multibillion-dollar annual sales potential."
Roughly 36 million people worldwide are believed to have the disease, and its prevalence is expected to grow as the world's population lives longer. By 2050, the number of North Americans aged 65 and older with Alzheimer's may triple, according to the Alzheimer's Association.
The newly released data did not show that solanezumab offered protection against the loss of physical function.
But it will likely lend further credence to the theory that Alzheimer's must be attacked early in the progression of the disease for drugs to have an impact.
Dr. Ronald Petersen, director of the Mayo Clinic Alzheimer's Disease Research Center in Rochester, Minnesota, threw out a note of caution about the drug's prospects.
"What you are seeing in the data is statistically significant," he said. "But it's hard to say that this is going to be meaningful clinically."
Dr. David Drachman, professor of neurology at the University of Massachusetts Medical School, questioned the significance of pooled memory findings culled from failed studies.
"The data can not be regarded as significant," he said. "They did not prove it works."
Initial data unveiled in August created doubts about whether the Lilly drug could be approved by the FDA without large new studies. It followed disappointing results for Pfizer's and Johnson & Johnson's bapineuzumab, which also failed in pivotal studies. Both treatments block a protein called beta amyloid that forms plaque deposits on the brain.
