Eisai to Present Three-Year Data on Lecanemab at Alzheimer's Conference 2024

Eisai Co. Ltd., headquartered in Tokyo and led by CEO Haruo Naito, announced that it will be presenting its latest research findings on Alzheimer’s disease (AD) at the Alzheimer's Association International Conference (AAIC) in Philadelphia and virtually from July 28 to August 1, 2024. The focus will be on Eisai's dual-acting, anti-amyloid beta (Aβ) protofibril antibody, lecanemab, also known as LEQEMBI® in the U.S., which is used for treating early AD.

Lecanemab stands out as the only available treatment for early AD that supports neuronal function by clearing toxic protofibrils, which continue to harm neurons even after the plaques are removed. Eisai's findings will be highlighted through four oral and 15 poster presentations, with two sessions specifically dedicated to lecanemab.

One of the key sessions titled "Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease?" will take place on July 30 from 4:15 p.m. to 5:45 p.m. EDT. This session will delve into critical issues such as the rationale for continued lecanemab dosing, the support for maintenance dosing through simulation models, and the evidence for long-term benefits from continued treatment. Notable experts like Dennis Selkoe, M.D., will discuss the toxicity of soluble aggregated amyloid-beta species, and how lecanemab's mechanism of action binds to these toxic forms even after plaque clearance. This session aims to offer mechanistic justifications for ongoing treatment to maintain both clinical and biomarker efficacy.

Clinical pharmacology data from the Phase II Study 201 and the Phase 3 Clarity AD study will also be examined, providing insights into lecanemab maintenance dosing. The importance of continuous administration of lecanemab was highlighted by data showing benefits from an intervening off-treatment period between the core phase and the open-label extension (OLE) of these studies.

Additionally, Christopher van Dyck, M.D., will present 36-month efficacy and safety data from the Phase 3 Clarity AD core and OLE studies. This presentation will offer insights into the potential benefits of continuous treatment for AD, a progressive neurodegenerative disease that persists even after plaque removal.

Another significant session titled "Beyond Amyloid Removal with Lecanemab Treatment: Update on Long-Term Imaging and Fluid Biomarkers" will be held on July 30 from 2:00 PM to 3:30 PM EDT. During this session, Dr. Brian Willis and Dr. Arnaud Charil will discuss the results of recent pharmacokinetic/pharmacodynamic (PK/PD) modeling and its connection to amyloid PET, CDR-SB, and tau PET outcomes from the Clarity AD studies. Dr. Nick Fox will explain the changes in brain volume associated with anti-amyloid immunotherapy and its potential link to amyloid clearance. Dr. Charlotte Teunissen will also present findings on neurodegenerative biomarkers in plasma resulting from long-term treatment with lecanemab, emphasizing the need for maintenance treatment based on these biomarker changes.

Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research at Eisai Inc., stated that the results to be presented at AAIC 2024 from the Phase 2 and Phase 3 lecanemab studies and open-label extensions highlight the potential long-term clinical and biomarker benefits of ongoing dosing with dual-acting lecanemab.

Eisai's comprehensive research at AAIC 2024 underscores the urgency and importance of early and ongoing treatment for AD to slow its progression, offering new hope and insights into effective disease management strategies.