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 Clinical Trials on Alzheimer’s Disease (CTAD) conference.
The drug, Leqembi (lecanemab-irmb), was granted traditional approval in the US earlier this year 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 decision, which made Leqembi the first approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and 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.
The recent SC sub-study included 72 patients who received Leqembi for the first time as the SC formulation and 322 patients who received the drug’s IV form in the Clarity AD core study followed by SC administration.
The results presented at CTAD showed that weekly SC administration of Leqembi removed 14% more amyloid plaque than the approved bi-weekly IV formulation after six months of treatment.
Additionally, blood concentration levels of the drug were 11% higher with SC Leqembi than the IV version.
Eisai said it aims to apply for US approval of SC Leqembi by the end of March next year.
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.
Eisai also presented an analysis of a small subgroup of patients from CLARITY AD who had earlier stages of Alzheimer’s and low levels of tau protein.
In the low-tau sub-population, 76% of the Leqembi group showed no deterioration and 60% showed clinical improvement after 18 months of treatment, compared with 55% and 28% of the placebo group, respectively.
Leqembi treatment also showed a consistent clinical response across multiple endpoints, including other measures of cognition.