An Alzheimer’s Win: How Lilly Designed Donanemab Trial To Succeed

Phase II Results May Support Accelerated Approval

 
• By Mandy Jackson
  
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Lilly took a different path to positive results in Alzheimer’s with a smaller, biomarker-driven study to test the hypothesis that rapid, robust clearance of amyloid could slow disease progression, CEO David Ricks explains at J.P. Morgan.

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Lilly CEO David Ricks outlined the path to Phase II success for donanemab in Alzheimer's disease • Source: Shutterstock

Eli Lilly and Company has learned a lot about what it takes to fail in Alzheimer’s disease drug development and applied those lessons to its next-generation anti-amyloid antibody donanemab, CEO David Ricks said on the second day of the J.P. Morgan Healthcare Conference. Ricks described how the company used what it learned to design the Phase II TRAILBLAZER clinical trials of donanemab for success, as seen in positive top-line results from the first study, which were reported on the first day of the virtual meeting.

It remains to be seen whether the US Food and Drug Administration and other regulators will be receptive to Lilly’s...

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