Eli Lilly said Tuesday that it has altered the primary endpoint of a Phase III study investigating solanezumab in people with mild Alzheimer's dementia to include a single assessment of cognition. Previously, the EXPEDITION3 trial had co-primary endpoints of cognition and function, but the company noted that the change reflected "emerging scientific evidence" that cognitive decline precedes and predicts functional decline in Alzheimer's disease, particularly in earlier stages of the condition. Eli Lilly added that it will continue to remain blinded to study data until after the database lock occurs in the fourth quarter.
According to Eli Lilly, the change will not affect the conduct of the trial. Specifically, the company will continue to assess cognition using the Alzheimer's Disease Assessment Scale-Cognitive subscale, while functionional outcome will be evaluated as previously designed, using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living instrument and Functional Assessment Questionnaire. The drugmaker plans to evaluate both functional outcomes as key secondary endpoints of the trial.
Eli Lilly said it is submitting the amendment to the trial to all global regulatory authorities. The drugmaker, which noted that EXPEDITION3 is the first Phase III study to evaluate only people with mild Alzheimer's dementia, initiated the trial after other late-stage study data suggested a benefit of early treatment with solanezumab among people with mild Alzheimer's disease.
Jefferies & Co. analyst Jeffrey Holford suggested last July that, if approved, solanezumab could generate peak annual sales of more than $3 billion worldwide.
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