Eisai to Present Dual-Acting Lecanemab Three Year Efficacy and Safety Data And Discuss Long-Term Outcomes of Continued Treatment at the Alzheimer's Association International Conference 2024

TOKYO, July 23, 2024 - (JCN Newswire) - Eisai Co. Ltd announced today that the company will present the latest findings on its Alzheimer’s disease (AD) pipeline and research, including our dual-acting, anti-amyloid beta (Aβ) protofibril* antibody for the treatment of AD, lecanemab (generic name, U.S. brand name: LEQEMBI®), at the Alzheimer’s Association International Conference (AAIC). Dual-acting lecanemab is the only early AD treatment available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain. The conference will be held in Philadelphia and virtually from July 28 to August 1, 2024. Eisai will present data and research in four (4) oral and 15 poster presentations at the meeting and will host two (2) sessions on lecanemab.

Perspectives Session: Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease?

- On July 30 from 4:15 p.m. to 5:45 p.m. EDT, Eisai will present the latest data exploring three critical topics:

1. Does the current evidence for lecanemab mechanism support a rationale for continued lecanemab dosing?
2. Is the lecanemab maintenance dosing regimen supported by simulation models?
3. Is there evidence for a continued benefit for long-term lecanemab treatment?

- Dennis Selkoe, M.D., will focus on the toxicity of soluble aggregated amyloid-beta species, including oligomers, protofibrils and diffusible fibrils. The session will review the latest data on the mechanism of action of lecanemab, which binds to protofibrils and oligomers that continue to be produced even after plaques are cleared. Additional discussion will focus on the potential mechanistic justification for ongoing treatment to maintain clinical and biomarker efficacy.

- Data from an intervening off-treatment period (gap period) occurring after the completion of the core phase of the Phase II Study 201 and before the initiation of the open-label extension (OLE) suggested the importance of continued administration of lecanemab. Youfang Cao, PhD., and Larisa Reyderman, Ph,D., from Eisai will present clinical pharmacology data and clinical pharmacology modeling outcomes that combine the outcomes from Study 201 and the Phase 3 Clarity AD study, which will provide insights into potential lecanemab maintenance dosing.

- Christopher van Dyck, M.D., will present the latest 36-month efficacy and safety data from dual-acting lecanemab’s Phase 3 Clarity AD core and OLE studies and panelists will discuss the potential benefits of continuous treatment of AD, which is a progressive, neurodegenerative disease that begins before plaque deposition and continues after plaque removal.

Featured Research Session: Beyond Amyloid Removal with Lecanemab Treatment: Update on Long-Term Imaging and Fluid Biomarkers.

- In this Featured Research session on July 30 from 2:00 PM to 3:30 PM EDT, the latest findings on imaging and fluid biomarkers from dual-acting lecanemab treatment will be presented.
- Brian Willis, PhD., and Arnaud Charil, PhD of Eisai will present the outcomes of recent PK/PD modeling examining the potential connection between dual-acting lecanemab’s PK and amyloid PET, CDR-SB, and the outcomes of the tau PET from Carity AD core and OLE studies.
- Nick Fox, M.D., FRCP, FMedSci, will explain the changes in brain volume that occur with anti-amyloid immunotherapy and its potential relationship to amyloid clearance.
- Charlotte Teunissen, PhD., will present data on neurodegenerative biomarkers in plasma as a result of long-term treatment of dual-acting lecanemab, and will also explain the necessity for maintenance treatment from these changes in biomarkers.

“At AAIC 2024, Eisai will present the results from the Phase 2 and Phase 3 lecanemab studies and open label extensions exploring ongoing dosing with dual-acting lecanemab for potential longer-term clinical and biomarker benefit,” said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research at Eisai Inc. “Alzheimer’s disease (AD) is a progressive and relentless disease caused by a continuous underlying neurotoxic process. There is an urgency to treat because early and ongoing treatment can slow the progression of Alzheimer’s disease. The earlier mild cognitive impairment (MCI) due to AD and mild AD dementia are diagnosed and treated, the greater the opportunity for the patient to benefit.”

For more information, visit https://www.eisai.com/news/2024/pdf/enews202453pdf.pdf.