The trial enrolled 1,795 subjects with early Alzheimer’s disease. Credit: Rad Cyrus on Unsplash.

Eisai and Biogen reported positive data from a Phase III clinical trial of the anti-amyloid antibody lecanemab (BAN2401) to treat Alzheimer’s disease (AD)-associated mild cognitive impairment and mild AD with established amyloid pathology in the brain.

According to topline results, lecanemab met its primary endpoint of change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) over 18 months in the 1,795-patient Phase III Clarity AD trial (NCT03887455). Lecanemab treatment reduced clinical decline relative to a placebo by 27% along CDR-SB, representing a score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat population. CDR-SB is an 18-point scale that combines cognitive and functional outcomes to measure the severity of dementia symptoms.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Lecancemab is the first of a series of high-profile AD trial readouts expected at the end of 2022 and early 2023. The antibody targets amyloid plaque accumulation in the brain, a popular yet controversial therapeutic target in AD. Biogen‘s Aduhelm (aducanumab), which also targets amyloid plaque, has faltered in the market after gaining FDA accelerated approval in July 2021.

Clarity AD also met all key secondary endpoints of ariation from baseline in amyloid positron emission tomography (PET) using Centiloids, AD Assessment Scale-Cognitive Subscale 14 (ADAS-cog14), and AD Composite Score (ADCOMS) at 18 months. In the lecanemab and placebo arms, the occurrence of amyloid-related imaging abnormalities-oedema/effusion (ARIA-E) were 12.5% and 1.7%, respectively.

Eisai plans to seek marketing authorisations in Japan and Europe, as well as a traditional approval for the antibody in the US by the end of March next year. 

In yesterday’s press release, Eisai CEO Haruo Naito said: “The lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of Alzheimer’s disease when targeted with a protofibril-binding therapy. Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

An investigational humanised monoclonal antibody, lecanemab attaches to neutralise and remove soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils). In November last year, the companies reported that Aduhelm (aducanumab-avwa) substantially lowered plasma p-tau181 in Phase III EMERGE and ENGAGE trials.