Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.

Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.

A look at TRAILBLAZER-ALZ 2

The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…

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  • July 25, 2023
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Donanemab slows cognitive decline in early Alzheimer’s patients by 35%

Lilly’s (NYSE:LLY) shares were up more than 5.36% to $425.88 after the company announced upbeat results from the phase 3 TRAILBLAZER-ALZ 2 study, which revealed that the experimental Alzheimer’s drug donanemab significantly slowed cognitive decline in patients with early symptomatic Alzheimer’s disease at 18 months.

Almost half of patients, 47%, who received donanemab had no disease progression one year after treatment began, compared with 29% who did not receive the investigational antibody. Donanemab recipients had a clinical decline of 35% compared to placebo recipients based on the primary outcome measure. The drug group had 40% less decline in the ability to perform activities of daily living.

A potential blockbuster

Donanemab seems likely to win FDA approval given the positive data. In September 2022, UBS projected that donanemab would generate peak risk-adjusted sales of $4.8 billion. But earlier this year, FDA sent Lilly a complete response …

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  • May 3, 2023
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