In the trial, donanemab lowered the risk of disease progression and half of the participants who were at an earlier stage of the disease and administered with donanemab had no clinical progression at one year
Lilly’s donanemab shows positive results in Phase 3 TRAILBLAZER-ALZ 2 study. (Credit: Colin Behrens from Pixabay)
Eli Lilly and Company has announced that donanemab significantly slowed the cognitive and functional decline in early symptomatic Alzheimer’s disease (AD) patients in the Phase 3 TRAILBLAZER-ALZ 2 study.
The findings from the study support Lilly’s application for regulatory approval to treat people with amyloid-positive early symptomatic AD, regardless of their baseline level of tau.
In the trial, donanemab also lowered the risk of disease progression. Half of the participants who were at an earlier stage of the disease and administered with donanemab had no clinical progression at one year.
The analysis of additional subpopulations revealed that research participants in the earliest stages of the illness benefited even more, with a 60% slowdown of decline in comparison to the placebo.
Additionally, even though many patients finished their therapy at 6 or 12 months, the treatment impact increased over the course of the trial relative to placebo, supporting limited duration dosage.
Eli Lilly and Company executive vice president Anne White said: “The positive TRAILBLAZER-ALZ 2 data bring hope to people with Alzheimer’s disease who urgently need new treatment options. This is the first Phase 3 study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study.
“If approved, we believe donanemab can provide clinically meaningful benefits for people with this disease and the possibility of completing their course of treatment as early as 6 months once their amyloid plaque is cleared.
“We must continue to remove any barriers in access to amyloid-targeting therapies and diagnostics in an already complex healthcare ecosystem for Alzheimer’s disease.”
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants ages 60-85 years with early symptomatic AD.
It recruited 1736 participants, across 8 nations, based on the cognitive assessments in combination with amyloid plaque imaging and tau staging by PET imaging.
Lilly is also planning to assess the drug in multiple clinical trials, including TRAILBLAZER-ALZ 3, TRAILBLAZER-ALZ 5 and TRAILBLAZER-ALZ 6.
Previously, the firm announced in May that donanemab has met the primary endpoint and all secondary endpoints in the phase 3 trial.