Eisai Presents Latest Alzheimer's/Dementia Pipeline Data at CTAD 2019, Highlighting BAN2401, Lemborexant, and Blood-Based Diagnostic

TokyoDecember 25, 2019/PR Newswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; hereinafter referred to as “Eisai”) announced that it delivered three oral presentations and eight poster presentations at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held in San Diego, California, USA, from December 4 to 7, 2019. The presentations highlighted the latest data from its Alzheimer’s disease/dementia drug pipeline, including anti-amyloidβ（Aβ) The anti-amyloid fibril antibody BAN2401, the orexin receptor antagonist lemborexant, and a simple blood-based diagnostic test for Alzheimer’s disease (AD). BAN2401 was jointly developed by Eisai and Biogen (headquartered in Cambridge, Massachusetts, USA). In addition, Eisai and Sysmex Corporation (headquartered in Kobe, Japan; hereinafter referred to as “Sysmex”) are jointly developing a simple blood-based diagnostic test for Alzheimer’s disease.

For BAN2401, at the start of the open-label extension phase of the Phase II study (Study 201), patients with early Alzheimer’s disease had brain AβThe sustainability of the horizontal will be presented at the “Late-Breaking Oral Communications Session.” Study 201 is the first to successfully demonstrate effects on clinical function and intracerebral beta-amyloid (Aβ) Later-stage studies accumulating evidence of potential disease-modifying effects. Furthermore, the study design and current status of the ongoing Clarity AD (Study 301) will be presented.

Additionally, further data analysis results from the Phase II clinical study (Study 202) of the investigational sleep-wake regulator lemborexant will be presented for Alzheimer’s disease patients with Irregular Sleep-Wake Rhythm Disorder (ISWRD).

Furthermore, regarding the simple blood diagnostic test for Alzheimer’s disease (AD) jointly developed with Sysmex, we will present the latest data on the fully automated protein analysis system utilizing Sysmex’s HISCL™ series, an automated immunoassay platform for protein measurement.

Leveraging over 35 years of experience in drug research within the field of Alzheimer’s disease and dementia, Eisai is committed to the prevention and treatment of dementia through a comprehensive R&D approach for dementia medications. Eisai will continue to dedicate itself to the development of innovative drugs, aiming to further meet the urgent medical needs of patients and their families and contribute to enhancing their well-being.

Oral Presentation

Product, Meeting Number

Title and Scheduled Presentation Date (Local Time: Pacific Time)

BAN2401

Meeting No. LB10

Durability of BAN2401-Mediated Amyloid Reduction Following Treatment:
Preliminary Comparison of Baseline Amyloid Status in the Core Phase and Open-Label Extension Phase of BAN2401-G000-201 in Patients with Early Alzheimer’s Disease
December 5 (Thursday), 11:15-11:30

Elenbecestat
Meeting Number LB16

Relationship between Neuraceq Levels and [18F]PI-2620 Tau PET Tracer Uptake at Baseline Scan in the Elenbecestat MISSION AD Program
Friday, December 6, 8:30–8:45

BAN2401 (presented by BioArtical)
Meeting Number OC29

Binding Profiles of BAN2401 and Aducanumab to Different Amyloid-Beta Proteins
December 7 (Saturday), 11:30–11:45

Poster Display

Product/Asset, Poster Number

Title and Scheduled Presentation Date (Local Time: Pacific Time)

Lemborexant

P3

Evaluating the Efficacy of Lemborexant in Patients with Irregular Sleep-Wake Rhythm Disorder and Alzheimer’s Disease Dementia Using Network Analysis and Machine Learning Methods
Wednesday, December 4 and Thursday, December 5

Elenbecestat

P24

Cognitive Task Group: A Novel Approach to Enhance the Efficiency of Cognitive Screening in the Elenbecestat MISSION AD Study
Global Phase 3 Study on Early Alzheimer’s Disease on December 4 (Wednesday) and December 5 (Thursday)

Elenbecestat

P46

Characteristics of Amyloid-Positive Subjects in the Phase 3 Elenbecestat MISSION AD Program
December 4 (Wednesday) and December 5 (Thursday)

Hematological Diagnosis

P75

Prediction of Amyloid Pathology by Measuring Plasma Aβ1-42/Aβ1-40 Ratio Using a Fully Automated Immunoassay System (HISCL™ Series)
Wednesday, December 4 and Thursday, December 5

Blood Diagnosis

P81

Clinical Application of Immunoenrichment Coupled with LC-MS/MS for the Determination of Plasma Amyloid-Beta Protein
Wednesday, December 4 and Thursday, December 5

Clinical Assessment

P136

Staging Early Alzheimer’s Disease Using the Alzheimer’s Disease Composite Score (ADCOMS)
Friday, December 6 and Saturday, December 7

Elenbecestat

P149

In the global Phase 3 MISSION AD study of Elenbecestat for early Alzheimer’s disease, the MMSE scores of screened patients in Asian and non-Asian countries were similar, conducted on December 6 (Friday) and December 7
Day (Saturday)

BAN2401

P179

BAN2401 in Early Alzheimer’s Disease:
A placebo-controlled, double-blind, parallel-group, 18-month study, en-
Use an open-label extension phase to confirm safety and efficacy
Friday, December 6 and Saturday, December 7