Biogen and Eisai’s Alzheimer’s disease drug has shown promise as a subcutaneous (SC) formulation, according to new data presented by Eisai at this year’s Alzheimer’s Association International Conference (AAIC).
The drug, Leqembi (lecanemab-irmb), was granted traditional approval in the US earlier this month for use in patients with mild cognitive impairment or early-stage Alzheimer’s disease as a bi-weekly intravenous (IV) infusion.
The US Food and Drug Administration’s (FDA) decision, which made Leqembi the first approved anti-amyloid Alzheimer’s disease treatment shown reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease, was supported by data from the phase 3 confirmatory Clarity AD clinical trial.
The study met its primary endpoint, reducing clinical decline by 27% on the global cognitive and functional scale compared with placebo at 18 months.
All multiplicity-controlled secondary endpoints also showed highly statistically significant results compared with placebo, including other measures of cognition and daily function.
New results from an exposure/bioavailability and modelling study, presented at AAIC, show a SC dose of Leqembi administered once-weekly may result in comparable exposure and efficacy to current bi-weekly IV dosing.
Additionally, models developed with data following IV administration show that amyloid-related imaging abnormalities with edema/effusion (ARIA-E) are related to concentrations of Leqembi in the blood, with maximum blood concentrations being the best predictor of ARIA-E.
Because SC dosing will have lower maximum blood concentrations than IV dosing, SC dosing is predicted to have a lower incidence of ARIA-E.
The results from a further analysis of CLARITY AD were also presented at AAIC and demonstrate the benefits of Leqembi on both amyloid-beta and tau, two underlying pathological hallmarks of the condition.
Affecting more than 6.5 million Americans, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Eli Lilly also presented results from a late-stage study of its experimental Alzheimer’s drug at AAIC.
Lilly said it expects the FDA to decide by the end of this year whether to approve the drug, donanemab, adding that submissions to other global regulators are underway.