Lilly Drug Found to Slow Alzheimer’s Disease Progression
Indianapolis-based Eli Lilly and Co.’s (NYSE: LLY) donanemab was found to have slowed Alzheimer’s disease progression in a Phase 2 trial. Results of the Phase 2 TRAILBLAZER-ALZ were presented at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases, held virtually March 9-14.
The company says data found donanemab “met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer’s Disease Rating Scale, a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer’s disease.”
“We are confident in the results of the TRAILBLAZER-ALZ study,” said Dr. Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “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.”
Additionally, Lilly says data from secondary analyses showed donanemab consistently slowed cognitive and functional decline. Specifically, at 76 weeks compared to baseline, treatment with the drug slowed decline by 32% compared to placebo.
“Tau has become increasingly validated as a predictive biomarker for Alzheimer’s disease progression, as shown again in this trial,” said Dr. Liana Apostolova, professor in Alzheimer’s disease research at IU School of Medicine. “A key insight of the results from the TRAILBLAZER-ALZ study is that donanemab not only significantly reduced the amount of amyloid deposition in these patients but also slowed the clinical progression of the disease suggesting that this could be a disease-modifying therapy. We believe these amyloid and tau imaging data lay the foundation for precision medicine-based Alzheimer’s disease treatments.”
Lilly says the safety profile of donanemab was consistent with observations from Phase 1 data.