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In a report published Wednesday, Evercore ISI analyst Mark Schoenebaum said that
Eli Lilly and CoLLY had provided additional data in mild Alzheimer's disease (AD) patients from EXPEDITION-EXT, the extension study to the Phase 3 EXPEDITION 1 and 2 trials of solanezumab.
Analyst Mark Schoenebaum wrote, "The data today appear consistent with previously presented extension data and suggests (if solanezumab proves to be effective in treating AD) a potential benefit from the earlier start of treatment and builds the case for the possible disease modification claim on the label."
While the FDA described "a randomized-start design…[as] a more convincing means of demonstrating" disease modification, Schoenebaum believes that the FDA was "still wrestling with this concept." Therefore, the data released may be seen as "incrementally positive" but not "thesis or stock changing."
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