Unknown Manufacturer • 用于治疗阿尔茨海默病。
Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease (AD). It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD. A phase II study conducted by Eli Lilly and published in March 2021 (TRAILBLAZER-ALZ), which looked at 257 patients with early symptomatic AD, found that patients receiving donanemab experienced a roughly 30% slower progression in AD as measured by a disease rating scale (iADRS), although results for secondary endpoints were mixed. In March 2021, Eli Lilly announced an expanded trial, named TRAILBLAZER-ALZ 2, which will seek to confirm the results of the first trial with an expanded patient population in order to address some of the deficiencies of the original.
Donanemab is presumed to exert its therapeutic effects by clearing amyloid beta (Aβ) plaques in the brain, though a clear link between plaque reductions and clinical outcomes was not observed in initial trials. Donanemab is a monoclonal antibody targeted against a specific epitope on a form of post-translationally modified Aβ plaque seen only in the brains of patients with Alzheimer's Disease, namely the N-terminus of pyroglutamate Aβ - after binding, donanemab induces microglial-mediated clearance of these plaques.
