Eli Lilly’s Alzheimer’s disease (AD) drug Kisunla (donanemab) has demonstrated a growing benefit over three years in patients with early symptomatic cases of the neurodegenerative disease, according to results from a long-term extension (LTE) study.
The phase 3 TRAILBLAZER-ALZ 2 LTE enrolled patients who completed the 76-week placebo-controlled period in the core trial and lasted an additional 78 weeks.
Data presented at this year’s Alzheimer’s Association International Conference (AAIC) showed that Kisunla reduced cognitive decline by -0.6 at 18 months and -1.2 at 36 months on the Clinical Dementia Rating Sum of Boxes in patients initially treated with Kisunla in the core study compared to an untreated external cohort from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
Beginning treatment with Kisunla earlier lowered the risk of progression to the next stage of disease by 27% on the Clinical Dementia Rating-Global Score compared to a delayed initiation group, while over 75% of Kisunla-treated patients achieved amyloid clearance within 76 weeks of starting treatment.
Amyloid plaque reaccumulation also remained slow for patients who had completed treatment, and no new safety signals were observed in the LTE over the three years.
More than seven million people in the US are affected by AD, which progressively destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Kisunla, approved in countries including the US and UK, is administered as a monthly intravenous infusion and designed to help the body remove the excessive buildup of amyloid plaques in the brain associated with AD.
Mark Mintun, group vice president, neuroscience research and development, Eli Lilly, said: “The TRAILBLAZER-ALZ 2 LTE reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile.
“Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention.”
The results come just days after donanemab was recommended by the European Medicines Agency’s human medicines committee to treat adults with early symptomatic AD.
The Committee for Medicinal Products for Human Use (CHMP) specifically recommended that the drug be approved to treat patients with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.