A positive Phase 2 Trial of Eli Lilly’s donanemab, an investigational antibody, has shown significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease.
Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by 32% relative to placebo, which was statistically significant. 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.
The full results of the TRAILBLAZER-ALZ study will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal. Lilly plans to discuss these results with regulators to assess next steps for donanemab. In addition, TRAILBLAZER-EXT is an ongoing trial for those who participated in TRAILBLAZER-ALZ.
Mark Mintun, M.D., vice president of pain and neurodegeneration, Eli Lilly and Company 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. We look forward to discussing the TRAILBLAZER-ALZ study data and next steps with global regulators. In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2. 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.”
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories said: “This unique mechanism and antibody for clearing plaques, discovered at Lilly, has the potential to provide high levels of durable amyloid plaque clearance after limited duration dosing. In conjunction with our expertise in amyloid and tau imaging, this allowed us to conduct a trial to test if reducing amyloid plaques in Alzheimer’s patients to levels seen in scans of healthy individuals could result in clinically meaningful slowing of cognitive decline. The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer’s disease.”