Japan – Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Dec 1, 2022 | Business

Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, in San Francisco, California and virtually.
Figure 1: CDR-SB as Primary endpoint change (18 months)


Summary of Presentations in the Scientific Session featuring Lecanemab at CTAD

Design of Clarity AD Study

Eisai’s Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia. The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup (MCI due to AD or mild AD), presence or absence of concomitant approved AD symptomatic medication at baseline (e.g., acetylcholinesterase inhibitors, memantine, or both), ApoE4 status and geographical region. Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants. As a result of Eisai’s recruitment strategy of diversity in the Clarity AD study, 4.5% and 22.5% of the randomized participants in the U.S. were Black and Hispanic, respectively.

The primary endpoint was change from baseline at 18 months in the CDR-SB1 (Clinical Dementia Rating Sum of Boxes), the global cognitive and functional scale, and key secondary endpoints were the change from baseline at 18 months in amyloid Positron Emission Tomography (PET) using Centiloids, AD Assessment Scale – Cognitive Subscale 14 (ADAS-Cog142), AD Composite Score (ADCOMS3) and AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL4). In addition, longitudinal changes in brain tau pathology as measured by tau PET (n=257) and cerebrospinal fluid (CSF) biomarkers of AD pathology (n=281) were evaluated in optional sub-studies.

Efficacy Results of Clarity AD

Mean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45 (95% Confidence Interval (CI): -0.67, -0.23; P=0.00005), representing a 27% slowing of decline. Starting as early as six months (difference: -0.17 [95% CI: -0.29, -0.05]; P

All key secondary endpoints also showed highly statistically significant results compared with placebo (P

For more information, visit www.eisai.com/news/2022/pdf/enews202285pdf.pdf.

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Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation

Dec 24, 2021 | Business

Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA.

In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License application (BLA) for lecanemab under the accelerated approval pathway. The BLA is primarily based on clinical, biomarker and safety data from the Phase 2b clinical study (Study 201) in people with early AD and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted. The lecanemab Phase 2b study results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit.

The lecanemab Clarity AD Phase 3 clinical study in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD is included to support the ongoing rolling submission. Another Phase 3 clinical study, AHEAD 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. Additionally, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study.

Alzheimer’s Disease is a serious, progressive and devastating disease with few treatment options. Eisai and Biogen are committed to bring new treatment options to people living with early AD, their families and healthcare professionals who are waiting for them as early as possible.






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