Eli Lilly and Company has reported that data from Phase II TRAILBLAZER-ALZ study of its investigational antibody, donanemab, showed a significant slowing of decline in patients with early symptomatic Alzheimer’s disease.
Donanemab targets a modified form of beta-amyloid called N3pG.
The randomised, placebo-controlled, double-blind, multi-centre study enrolled 272 patients to analyse the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer’s disease.
Data from the trial showed that donanemab slowed decline by 32% versus placebo, thereby meeting the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS).
Though the antibody demonstrated consistent progress in all prespecified secondary endpoints analysing cognition and function versus placebo, it failed to reach nominal statistical significance on every secondary endpoint.
Eli Lilly and Company pain and neurodegeneration vice-president Mark Mintun 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.
“In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2.”
Furthermore, data showed that the treatment could rapidly result in high levels of amyloid plaque clearance.
Donanemab’s safety profile was in line with the one reported in Phase I part of the study.
Eli Lilly noted that the full results from the TRAILBLAZER-ALZ study will be reported soon and it intends to hold talks with regulators on the reported data.
Another trial, TRAILBLAZER-EXT, which enrolled the participants from TRAILBLAZER-ALZ is progressing.
In addition, an ongoing, randomised, placebo-controlled, double-blind, multi-centre Phase II TRAILBLAZER-ALZ 2 study is evaluating the safety, tolerability and efficacy of donanemab.