Eli Lilly Launches Phase IIIb Trial of Donanemab in 800 Patients to Evaluate ARIA-E Risk and Dosing Regimens in Early Alzheimer’s Disease

On February 22, Eli Lilly registered a Phase IIIb clinical trial (TRAILBLAZER-ALZ 6) on the clinicaltrials.gov website to evaluate the effects of different donanemab dosing regimens on the frequency and severity of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) in adults with early Alzheimer's disease (AD), and to explore subject characteristics that may predict ARIA risk.

Donanemab is an investigational antibody drug that targets a modified form of β-amyloid plaques known as N3pG, capable of rapidly clearing amyloid plaques. In June 2021, based on data from its Phase II TRAILBLAZER-ALZ study, the FDA granted the drug Breakthrough Therapy designation for the treatment of AD. In October of the same year, Eli Lilly and Company submitted a rolling application to the FDA for the drug's use in treating AD.

Its marketing application was based on the Phase III TRAILBLAZER-ALZ study (n=257), in which 131 patients received donanemab treatment. However, due to certain reasons, the number of patients who completed 12 months of treatment was less than 100. The results of the TRAILBLAZER-ALZ study showed that after 6 months of treatment, 37.9% of patients in the donanemab group achieved complete clearance of cerebral amyloid plaques, compared to only 1.6% in the Aduhelm group.

In January 2023, Eli Lilly announced that it had received a Complete Response Letter (CRL) from the FDA regarding the submission of donanemab for the treatment of early symptomatic Alzheimer's disease (AD). The FDA stated that the reason for refusing accelerated approval was insufficient data on patients who had received continuous treatment with donanemab for 12 months (at least 100 cases should be provided). The registration of new clinical trials this time also indirectly reflects that Eli Lilly has not abandoned the development of this drug, and we will continue to follow up on subsequent research progress.

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