Eli Lilly and Banner Alzheimer’s Institute have signed a strategic research collaboration to conduct a phase 3 prevention trial of donanemab.
The two partners will collaborate on a planned TRAILBLAZER-ALZ 3 trial evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s disease.
The Banner Institute will leverage its expertise in Alzheimer’s prevention trials and also support enrolment of trial participants with and without the APOE4 gene through the Alzheimer’s Prevention Registry’s GeneMatch programme.
As part of the collaboration, Lilly and Banner will introduce a more virtual approach to the evaluation of the potential Alzheimer’s therapy.
“Our TRAILBLAZER-ALZ 3 trial will evaluate whether donanemab can prevent clinical progression in patients who have evidence of Alzheimer’s pathology, but don’t yet demonstrate clinical symptoms,” said Mark Mintun, vice president of pain and neurodegeneration at Lilly.
“While these types of trials are challenging to enrol and conduct, Lilly, together with Banner, is proud to undertake the opportunity to bring about this new study in an area of high unmet medical need,” he added.
In June, the US Food and Drug Administration (FDA) Lilly’s donanemab a breakthrough therapy designation (BTD) based on results from the phase 2 TRAILBLAZER-ALZ study.
Top-line data from the TRAILBLAZER-ALZ trial in patients with early symptomatic Alzheimer’s showed that donanemab slowed cognitive decline by 32% on the Integrated Alzheimer’s Disease Rating Scale (iARDS) compared to placebo.
Lilly later reported that although secondary outcomes within this trial ‘showed no substantial difference’, exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in Alzheimer’s patients.
In addition, 40% of donanemab-treated patients achieved amyloid negativity as early as six months after starting treatment and 68% achieved this target by 18 months.
Donanemab is also being studied in the ongoing phase 3 TRAILBLAZER-ALZ 2 study in early symptomatic Alzheimer’s disease patients.
Lilly has enrolled patients in the expanded TRAILBLAZER-ALZ 2 study who have both high and intermediate levels of tau accumulation, but participants who have high tau levels will be excluded from the primary analysis of the trial.
The company is expecting to complete enrolment of participants in this study later this year, with data from the trial anticipated in early 2023.