Eli Lilly’s has expanded on previously reported top-line data for its Alzheimer’s drug candidate donanemab, with new data from secondary analyses reported.
Top-line data from the Phase II TRAILBLAZER-ALZ trial found that donanemab met its primary endpoint, showing significant slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS) in patients with early symptomatic Alzheimer’s compared to placebo.
Additional data from secondary analyses, presented at the virtual International Conference on Alzheimer’s & Parkinson Diseases 2021, showed that donanemab ‘consistently’ slowed cognitive and functional decline.
This ranged between 20-40% in all secondary endpoints, with nominal statistical significance at ‘multiple times’ compared to placebo.
Lilly also said that further prespecified exploratory analyses showed donanemab slowed the accumulation of tau tangles in the brains of treated patients.
In addition, 40% of participants treated with donanemab achieved amyloid negativity as early as six months after starting treatment, and 68% achieved this target by 18 months.
“The combination of changes in Alzheimer’s biomarkers and the slowing of clinical symptoms of the disease seen in this study is promising,” said Howard Fillit, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation.
“We are encouraged by today’s news, and if these results are confirmed in the larger study now in progress, donanemab could offer the potential for a disease-modifying therapy that can help patients maintain cognitive abilities and their independence longer. We eagerly await results from future trials,” he added.
Donanemab targets a modified form of beta amyloid called N3pG. By targeting N3pG, donanemab has been shown to result in high levels of amyloid clearance, according to Lilly.
