Eli Lilly’s Alzheimer’s drug slows clinical decline in Phase II trial
pharmafile | January 11, 2021 | News story | Sales and Marketing | Alzheimer's, Eli Lilly
Eli Lilly’s donanemab has shown significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo in results from its Phase II TRAILBLAZER-ALZ study.
The drug, an investigational antibody that targets a modified form of beta amyloid called N3pG, met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by 32% compared with placebo.
The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer’s disease. Donanemab also showed consistent improvements in all prespecified secondary endpoints measuring cognition and function compared to placebo, but did not reach nominal statistical significance on every secondary endpoint.
By targeting N3pG beta amyloid, donanemab treatment has been shown to rapidly result in high levels of amyloid plaque clearance, as measured by amyloid imaging. In TRAILBLAZER-ALZ, donanemab-treated patients showed an average of 84 centiloid reduction of amyloid plaque at 76 weeks compared to a baseline of 108 centiloids.
The safety profile of the drug was consistent with observations from Phase II data.
Dr Mark Mintun, Vice President of Pain and Neurodegeneration at Eli Lilly, said: “We are extremely pleased about these positive findings for donanemab as a potential therapy for people living with Alzheimer’s disease, the only leading cause of death without a treatment that slows disease progression.
“With more than 30 years of dedication to finding solutions for this devastating disease, we are proud of our progress moving the field forward and advancing the science. These positive results give us hope for patients and their families.”
Darcy Jimenez
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