Eli Lilly and Company has reported positive findings from the Phase III TRAILBLAZER-ALZ 2 trial of donanemab to treat early symptomatic Alzheimer’s disease (AD).
The results demonstrated that donanemab significantly slowed cognitive and functional decline in the targeted patients.
Donanemab also met the primary endpoint of change from baseline until 18 months as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS).
iADRS’ primary endpoint calculates cognition and activities of day-to-day activities, including the management of finances, driving, engaging in hobbies, as well as discussion on current events.
The trial also met all secondary endpoints of cognitive and functional decline.
On the basis of these data, Eli Lilly will apply for global regulatory approval. The company also plans to make a submission to the US Food and Drug Administration (FDA) this quarter.
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Furthermore, additional prespecified secondary evaluation of the trial revealed that 47% of patients receiving donanemab experienced no decline on the Clinical Dementia Rating-Sum of Boxes, a major way to measure disease severity at year one.
The evaluation also found that patients treated with donanemab had a 40% less decline in ability to perform daily living activities at 18 months, among others.
TRAILBLAZER-ALZ 2 is a randomised, double-blind, placebo-controlled trial.
It examined the safety and efficacy of donanemab, an investigational amyloid plaque-targeting therapy for the treatment of enrolled patients.
The trial included patients with early symptomatic AD, including mild cognitive impairment and the disease’s mild dementia stage, with confirmed presence of AD neuropathology.
Patients completed their donanemab treatment after reaching a prespecified amyloid plaque clearance level.
Eli Lilly chief scientific and medical officer, and Research Laboratories president Daniel Skovronsky said: “This is the first Phase III trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”