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Synonyms: BAN-2401 | BAN2401 | lecanemab-irmb | Leqembi®
lecanemab is an approved drug (FDA (2023))
Compound class:
Antibody
Comment: Lecanemab (BAN2401) is a humanized IgG1 monoclonal antibody that targets amyloid β protein (APP) protofibrils [1,7]. It binds more potently to amyloid β protofibrils than to monomeric amyloid β [1,6]. Lecanemab was developed by Eisai and Biogen for potential to slow neurological decline in patients in the very early stages of developing Alzheimer's disease. It is not suitable for other forms of dementia.
This blog post by Derek Lowe ('Lecanemab and Alzheimer's: More Data'; posted on Nov. 30, 2022) provides a sound review of lecanemab's reported efficacy [8], what it contributes as an Alzheimer's therapy, and the issues around potential lecanemab-mediated cerebral bleeding events. |
| No information available. |
Summary of Clinical Use  |
| The FDA designated lecanemab a breakthrough therapy in June 2021. It was also granted 'priority review' and was evaluated via the FDA's accelerated approval pathway which expedited its regulatory review. Lecanemab was the first drug to be approved by the FDA in 2023 [2]. Its use is indicated to treat patients with mild cognitive impairment or mild dementia stage of Alzheimer's disease. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT04468659 | AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid | Phase 3 Interventional | Eisai Inc. | ||
| NCT01230853 | A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study | Phase 1 Interventional | Eisai Inc. | 3 | |
| NCT03887455 | A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | Phase 3 Interventional | Eisai Inc. | The CLARITY AD study: Lecanemab's developers announced positive outcomes from this study in late September 2022. Following 18 months of treatment they detected reduced amyloid β in the brains of those patients given lecanemab, and significantly slower cognitive decline (reduced by 27%) compared to trial volunteers who received placebo. Full data analysis was published in the NEJM in November 2022. | 8 |
| NCT01767311 | A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease | Phase 2 Interventional | Eisai Inc. | 5 | |
| NCT05269394 | Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU) | Phase 2/Phase 3 Interventional | Washington University School of Medicine | E2814 is a monoclonal antibody that targets the microtubule-binding repeat domain of tau. This study is designed to evaluate the potential of immunodepleting either amyloid β alone (lecanumab) or amyloid β and tau (lecanumab + E2814) as Alzheimer's disease modifiers. | 4 |
