Eli Lilly (LLY) announced “positive results” from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer’s disease. The primary endpoint of the study was the proportion of participants with any occurrence of ARIA-E by week 24, and the results showed the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the standard dosing regimen, a 41% lower relative risk. The largest ARIA-E reduction with the modified titration was seen in apolipoprotein E homozygotes, carriers of a known genetic risk factor for developing Alzheimer’s disease. In these patients, 19% had ARIA-E on the modified titration as compared to 57% on the standard dosing regimen, resulting in a 67% lower relative risk. Lilly is discussing the results of this study with global regulators, with the intent to submit for a potential label update for Kisunla.
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