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INDIANAPOLIS, July 29, 2021 /PRNewswire/ -- Today at the Alzheimer's Association International Conference© (AAIC© 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In the first, greater amyloid plaque changes following donanemab treatment was highly associated with less cognitive decline and participants with greater plaque clearance at 24 weeks of treatment showed less tau progression. In the second, Lilly shared data showing that treatment with donanemab drives a rapid reduction of a biomarker reflecting Alzheimer's disease pathology, plasma P-tau217, which was detected within 12 weeks.
Donanemab is an investigational antibody that targets a modified form of beta amyloid plaque called N3pG. In June 2021, Lillyannounced the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data. No additional safety analyses were performed related to the presentations; for information on donanemab's safety profile, reference the previous publication.
"We are excited by these promising results, which provide further evidence on the potential for donanemab to slow disease progression for people with early symptomatic Alzheimer's disease," said Mark Mintun, M.D., vice president of pain and neurodegeneration, Lilly. "Importantly, these data link the mechanism of action of donanemab, plaque clearance, with positive effects on both clinical outcomes and brain tau pathology."
In the first oral presentation, donanemab induced rapid amyloid plaque reduction at 24 weeks in participants with early symptomatic AD, with the most rapid clearance in subjects with the most severe plaque burden at baseline. The subset of participants who reached complete amyloid plaque clearance at 24 weeks (defined as an amyloid level of
