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Eisai/Biogen present more data on antibody for Alzheimer’s disease

Phase 2 data shows lecanemab offers a consistent ‘robust’ effect against Alzheimer’s disease, while the phase 3 programme will test plasma biomarkers to identify preclinical disease


To succeed in the Alzheimer’s disease market, a new therapy will need to show a clear link between clinical markers such as screening data with real clinical outcomes.

To that end, Eisai and Biogen have presented a new analysis of their phase 2 data and sharing more information on their phase 3 programme for their co-developed antibody lecanemab in mild/early Alzheimer’s disease.

In September, Eisai and Biogen – which partnered on lecanemab in 2017 – submitted data from the phase 2 Study 201 as part of their rolling submission for an accelerated biologics licence application with the Food and Drug Administration (FDA), after the agency granted lecanemab breakthrough therapy status.

In Study 201, 856 patients with mild cognitive impairment or dementia and a confirmed presence of beta-amyloid deposits in the brain received either the antibody or placebo. Lecanemab is designed to specifically bind to a soluble, damaging version of the beta-amyloid protein, which clumps and builds into toxic plaques in Alzheimer’s disease, and promote its clearance before it can cause deposits.

While the study failed to meet its primary endpoint, it did show that brain amyloid was reduced and more than 80% of participants became amyloid negative by visual reads.

This week, Eisai and Biogen presented a new sensitivity analysis at the Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston, Massachusetts, based on an open-label extension.

“In Study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints,” said Dr Michael Irizarry, deputy chief clinical officer at Eisai. “This sensitivity analysis shows the lecanemab clinical efficacy results across statistical models are consistent and reliable, and further enhances our confidence in the clinical potential of this investigational therapy.”

Irizarry added that Eisai’s research programme would continue “to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical AD”.

Eisai and Biogen have also presented some insights around the first-of-its-kind biomarker screening process they are using in their phase 3 programme in preclinical Alzheimer’s disease.

The Ahead 3-45 study will ‘seek to determine the potential role of plasma-based biomarkers in the identification of cognitively unimpaired individuals most appropriate to move on to PET imaging, which is currently the standard of care to determine treatment approach’, said the companies.

“The screening process for Alzheimer’s disease can be time consuming and costly,” said Irizarry. “There is a need to accelerate and improve the efficiency of identifying individuals who may be eligible for current and future treatments based on cognitive testing and confirmation of elevated amyloid in the brain.”

His hope is that by incorporating plasma screening in their clinical study in preclinical Alzheimer’s disease, the novel approach will help identify people with elevated brain amyloid and reduce the need for diagnostic amyloid PET scans or spinal taps.

Article by
Hugh Gosling

12th November 2021

From: Regulatory



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