Eli Lilly and Company has released detailed results of a Phase II TRAILBLAZER-ALZ study that was conducted to determine the efficacy of investigational antibody donanemab for treating Alzheimer’s disease.
The detailed results were presented at the 15th International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021) that was held virtually last week, as well as published in The New England Journal of Medicine (NEJM).
The move comes around two months after Lilly reported positive data from the trial.
The randomised, placebo-controlled, double-blind, multi-centre study aimed to assess the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer’s disease.
It enrolled 272 patients selected on cognitive assessments, along with amyloid plaque imaging and tau staging by PET imaging.
According to the trial data, donanemab achieved its primary endpoint slowing decline by 32% versus placebo on the integrated Alzheimer’s Disease Rating Scale (iADRS) at 76 weeks compared to baseline.
The antibody also slowed cognitive and functional decline, with ranges between 20% to 40% in all secondary endpoints with nominal statistical significance.
Lilly Research Laboratories president Daniel Skovronsky said: “This is the first late-stage study in Alzheimer’s disease to meet its primary endpoint at the primary analysis.
“Donanemab has the potential to become a very important treatment for Alzheimer’s disease. We were pleased to see not only slowing of cognitive and functional decline, but also very substantial clearance of amyloid plaques and slowing of spread of tau pathology.
“The constellation of clinical and biomarker results indicates the potential for long-term disease modification. We are grateful to the patients, caregivers, and investigators who participated in this landmark study.”
TRAILBLAZER-ALZ 2 is currently underway, which is also testing the safety, tolerability and efficacy of donanemab in a randomised, placebo-controlled, double-blind, multi-centre study.