May 3, 2023

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Eli Lilly and Company (LLY) recently announced positive results from the TRAILBLAZER-ALZ 2 Phase 3 study, revealing that donanemab, an investigational amyloid plaque targeting therapy, significantly slows cognitive and functional decline in individuals with early symptomatic Alzheimer's disease. The study met its primary endpoint and all secondary endpoints, providing compelling evidence of the clinical benefits of donanemab. This breakthrough development brings hope to millions of people affected by Alzheimer's disease.

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Promising Findings from the Phase 3 Trial:

In the TRAILBLAZER-ALZ 2 trial, donanemab demonstrated remarkable results in slowing cognitive and functional decline. The primary endpoint, measured by the integrated Alzheimer's Disease Rating Scale (iADRS), showed a 35% reduction in decline compared to the placebo group over 18 months (p<0.0001). Additionally, the study met all secondary endpoints, with statistically significant clinical benefits observed across various measures of cognitive and functional decline.

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Positive Secondary Endpoint Results:

The positive results extended to several secondary endpoints. Notably, 47% of participants on donanemab showed no decline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) measure at the one-year mark, compared to only 29% of participants on placebo (p<0.001). This measure is crucial for evaluating disease severity. Moreover, participants on donanemab experienced a 40% less decline in their ability to perform activities of daily living at 18 months, as measured by the Alzheimer's Disease Cooperative Study – instrumental Activities of Daily Living Inventory (ADCS-iADL) (p<0.0001). These results indicate the potential of donanemab in preserving functional independence for individuals with early Alzheimer's disease.

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High Treatment Completion Rate:

The trial also reported an impressive treatment completion rate, with over half (52%) of all participants successfully completing their course of treatment within one year. By the 18-month mark, 72% of participants had completed their treatment due to achieving plaque clearance. This high completion rate reflects the tolerability and acceptance of donanemab by participants, highlighting its potential as a viable therapeutic option.

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Regulatory Submissions and Future Prospects:

With these encouraging findings, Eli Lilly intends to pursue global regulatory submissions promptly. The company plans to submit its data to the U.S. Food and Drug Administration (FDA) within this quarter. Eli Lilly aims to collaborate closely with regulatory authorities worldwide to expedite the approval process and provide patients with access to this innovative treatment.

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Safety Profile and Adverse Events:

During the study, donanemab demonstrated an acceptable safety profile. The most commonly observed adverse event was amyloid-related imaging abnormalities (ARIA), a known occurrence with amyloid plaque clearing antibody therapies. ARIA was primarily observed as temporary brain swelling (ARIA-E) or as microhemorrhages (ARIA-H). The incidence of ARIA was consistent with previous studies, and most cases were mild to moderate and resolved or stabilized with appropriate management. Infusion-related reactions were reported in 8.7% of participants, with the majority being mild to moderate in severity.

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Members of LevelFields received the alert of this event on May 3, 6:30 AM ET

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