Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo in results from Eli Lilly and Company's phase 2 study.
TRAILBLAZER-ALZ is a randomized, placebo-controlled, double-blind, multi-center phase 2 study to assess the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer's disease. According to data from the 272-patient study, participants who received the drug had a 32 percent deceleration in the rate of decline, compared with those who got a placebo.
Donanemab, a monoclonal antibody, binds to a small part of the hard plaques in the brain made of a protein, amyloid, that are hallmarks of Alzheimer’s disease. Destroying these beta amyloid plaques has long been hypothesized as a method of treatment, but proof has been hard to come by. "In conjunction with our expertise in amyloid and tau imaging, this allowed us to conduct a trial to test if reducing amyloid plaques in Alzheimer's patients to levels seen in scans of healthy individuals could result in clinically meaningful slowing of cognitive decline. The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer's disease," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.
The full results of the TRAILBLAZER-ALZ study will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal, according to Lilly. The drugmaker says it is committed to reproducing and extending these findings in a second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2.
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