Eli Lilly has shared positive results from a late-stage study of its amyloid plaque-targeting Alzheimer’s disease (AD) drug donanemab in adults with early symptomatic cases of the neurodegenerative disorder.
The phase 3b TRAILBLAZER-ALZ 6 trial has been evaluating the impact of different dosing regimens of donanemab on the rates of amyloid-related imaging abnormalities with oedema/effusion (ARIA-E) and amyloid clearance in adults with early symptomatic AD, including those with mild cognitive impairment and the mild dementia stage of disease.
An estimated 982,000 people are living with dementia in the UK, with AD accounting for up to 75% of cases.
Donanemab, approved under the brand name Kisunla in countries including the US and Great Britain, is administered as an intravenous infusion every four weeks and is designed to help the body remove the excessive buildup of amyloid plaques in the brain associated with AD.
The data presented at this year’s Clinical Trials on AD Conference showed a reduction of ARIA-E in patients receiving a slightly modified titration of donanemab, with an incidence of 14% compared to 24% for those being treated with the once-monthly standard dosing regimen.
The largest ARIA-E reduction with the modified titration was seen in carriers of apolipoprotein E, a known genetic risk factor for developing AD. In these patients, 19% had ARIA-E on the modified titration compared to 57% on the standard dosing regimen.
Patients on the modified titration also saw a reduction of amyloid plaque and P-tau217 comparable to those receiving the standard dosing regimen and, aside from the improvement in ARIA-E rates, safety profiles were comparable across the four arms.
Lilly said it is discussing the results of the study with global regulators, with the intent to submit for a potential label update for the drug.
Mark Mintun, group vice president neuroscience research and development, Eli Lilly, and president of Avid Radiopharmaceuticals, said: “We are confident in the benefits of Kisunla’s currently approved dosing regimen and are excited that these results reveal a path to potentially improving on Kisunla’s profile by reducing the risk of ARIA-E.
“The modified titration could offer continued convenience of once-monthly dosing and limited duration treatment while also reducing ARIA-E and maintaining similar amyloid plaque removal.”