Lilly's (LLY.US) Alzheimer's disease therapy hits primary endpoint in Phase 3b trial

Eli Lilly (LLY.US) today (October 30) announced that its TRAILBLAZER-ALZ6 clinical 3b study met its primary endpoint. At 24 weeks, the risk of amyloid-related imaging abnormalities - edema/effusion (ARIA-E) in adults with early symptoms of Alzheimer's disease (AD) receiving the adjusted Kisunla (donanemab) dosing regimen was significantly lower than the standard dosing regimen, and the adjusted dosing regimen was comparable to the standard regimen in terms of amyloid plaque and plasma P-tau217 reduction in the patients. Eli Lilly plans to submit this data to global regulatory agencies in an effort to update the donanemab label.

TRAILBLAZER-ALZ6 is a multi-center, randomized, double-blind 3b study designed to evaluate the impact of different donanemab dosing regimens on the incidence of ARIA-E and amyloid clearance in patients with early symptoms of AD, including those with mild cognitive impairment (MCI) and mild dementia. The primary endpoint of the study was the proportion of participants who experienced ARIA-E at week 24.

Donanemab is a monoclonal antibody targeting beta-amyloid that specifically binds to the N3pG subtype of amyloid. By targeting this subtype, donanemab is able to selectively bind to amyloid plaques in the brain, thereby promoting amyloid plaque clearance. The therapy was approved by the US FDA in July for the treatment of adults with early symptoms of AD. According to the press release, the monthly donanemab is the first amyloid plaque-targeting therapy with evidence that treatment can be stopped after amyloid plaque clearance, which is expected to reduce treatment costs and the number of infusions.