Eli Lilly's Solanezumab Is the Alzheimer's Drug Equivalent of the Internet Dress

WASHINGTON, D.C. (TheStreet) -- Remember the dress that took over the Internet last winter? To some people, the dress was most definitely blue and black, others insisted the dress was white and gold. People saw different colors in the dress based on their perceptions of the image and how their brains processed that information.

Eli Lilly's  (LLY) solanezumab is the Alzheimer's drug equivalent of the Internet dress. New data disclosed Wednesday has some people seeing hope that solanezumab, if used early enough, can slow the declines in cognition, memory and function that are the terrible hallmarks of Alzheimer's.

Others looking at the same solanezumab data see not much of anything. The drug appears to be safe, but it's not benefiting Alzheimer's patients in a meaningful way.

The new, contentious solanezumab data come from from Lilly's EXPEDITION-EXT study, to be presented Wednesday afternoon at the Alzheimer's Association International Conference in Washington, D.C. Lilly announced the sola data in a press announcement ahead of the presentation. The full study results were also published in the medical journal Alzheimer's & Dementia.

Lilly shares closed Tuesday down 2.5% to $85.72, ahead of Wednesday's data. However, shares of the pharmaceutical giant are up 24% this year, due in large part to investor excitement about the Alzheimer's program and high expectations for positive solaneuzumab (sola, for short) study results.

In an extended analysis of two large but negative clinical trials, Lilly scientists conclude that mild Alzheimer's patients who start treatment with sola early lose cognition and function at a slower rate than similar patients who start taking the drug later. The inability of "delayed-start" sola patients to catch up to early sola starters suggests the drug is having a positive, modifying effect on Alzheimer's, Lilly says.

Using a delayed-start trial design to assess the potential for a drug to slow disease progression has been tried before, but the sola results are the first time it's been used successfully with Alzheimer's patients, says Hong Liu-Seifert, the Lilly scientist who led the EXPEDITION-EXT study.

"The results support the potential benefit of starting treatment with solanezumab earlier rather than later in disease progression, and suggest there is persistence of treatment effect after the delayed-start patients are given the drug," said Dr. Paul Aisen, director of the Alzheimer's Therapeutics Research Institute at the University of Southern California, in a statement.

But not all Alzheimer's experts share Lilly and Aisen's optimistic view of the sola delayed-start data. An Alzheimer's doctor at the AAIC conference, who asked not be named because he didn't want to criticize colleagues publicly, views the small differences in measurements of cognition and function between early- and delayed-start sola patients to be clinically meaningless.

He also believes Lilly leaned heavily on extensive "modeling" of the raw data and unproven but generous statistical methods to reach its positive conclusions. "What we're seeing here is not a disease modifying effect," he says.

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