An experimental drug developed by Eli Lilly and Co. "significantly slowed cognitive and functional decline" in people with early symptomatic Alzheimer's disease, the company announced Wednesday.
In the TRAILBLAZER-ALZ 2 Phase 3 study, researchers found that nearly half of the senior participants in a study who took donanemab had no clinical progression after a year, compared with just 29% of participants taking a placebo.
The study enrolled more than 1,700 people with mild cognitive impairment and mild dementia, with the confirmed presence of Alzheimer's Disease neuropathology.
The drugmaker said treatment with the investigational amyloid plaque targeting therapy slowed cognitive decline by 35% compared to placebo, resulting in 40% less decline in the ability to perform activities of daily living at 18 months.
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Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared with those on the placebo.
More than half of all participants completed their course of treatment in a year's time.
The Eli Lilly drug met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer's Disease Rating Scale, which measures cognition and activities of daily living.
All secondary endpoints of cognitive and functional decline were also met.
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In a smaller number of participants with a later stage of disease progression, combined with the primary analysis population – those who had an "intermediate" level of the brain protein tau, a predictive biomarker for Alzheimer's disease progression – donanemab also demonstrated meaningful positive results across all clinical endpoints.
The company said, based on the presented results, it would make a submission to the Food and Drug Administration this quarter and will work with global regulators to achieve the fastest path to traditional approvals.
Eli Lilly noted that temporary swelling in an area or areas of the brain occurred in 24% of treated participants, and microhemorrhages or superficial siderosis occurred in 31.4% in the donanemab group and 13.6% in the placebo group. The majority of cases were mild to moderate and resolved or stabilized with "appropriate management."
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Two participants' deaths were attributed to the incidence of amyloid-related imaging abnormalities, and a third died after a serious case.
Full results of the study will be presented at the Alzheimer's Association International Conference in July and submitted for publication in a peer-reviewed clinical journal.
"Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer's disease by elucidating basic mechanisms of AD pathology and discovering imaging and blood biomarker tools to track the pathology," Dr. Daniel Skovronsky, Eli Lilly's chief scientific and medical officer, said in a statement. "We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer's disease in this trial."
