DIAN-TU Selects Lecanemab as Backbone Anti-Amyloid Therapy in Tau-Targeted Trial for Dominantly Inherited Alzheimer’s Disease
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TOKYO, Dec. 6, 2021 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by the Washington University School of Medicine in St. Louis, has reached an agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to modify the design of the foundational anti-amyloid drug clinical study (Tau NexGen). The Tau NexGen clinical study was initially focused on therapies targeting tau.
As an increasing amount of clinical research evidence shows that targeting amyloid can reduce biomarkers of Alzheimer's disease (AD), the principal investigators of the Tau NexGen clinical trial have selected Eisai's investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab as the foundational anti-amyloid agent.
The purpose of the Tau NexGen study is to evaluate the safety, tolerability, biomarkers, and cognitive efficacy of exploratory therapies in patients with Alzheimer's disease-causing gene mutations. The study will assess whether the investigational drug treatment can slow the progression of cognitive impairment and improve disease-related biomarkers.
Individuals known to have Dominantly Inherited Alzheimer's Disease (DIAD) gene mutations will develop AD and may begin to show symptoms at the same age as their affected parent, typically in their 50s, 40s, or even 30s. In March 2021, DIAN-TU selected E2814, an anti-Microtubule Binding Region (MTBR) tau antibody, which is a research outcome from the collaboration between Eisai and University College London, as the anti-tau drug for the DIAN-TU tau study.The FirstResearch drugs.
In the revised Tau NexGen study, symptomatic participants will receive lecanemab for six months and then be randomly assigned to receive either the anti-tau drug or a placebo. Since amyloid plaques accumulate before tau tangles in AD, this study design allows researchers to evaluate whether the removal of amyloid clears the way for the anti-tau drug to function most effectively. Before starting lecanemab administration, symptomatic participants will be randomly assigned to receive either the anti-tau drug or a placebo for one year.
By staggering the drugs, researchers will be able to evaluate the effect of the anti-tau drug independently before assessing the combination of the two drugs. The primary endpoint is the slowing of tau accumulation in the brains of symptomatic subjects, as shown on PET brain scans. As a secondary endpoint, researchers will assess whether the exploratory therapy affects levels of a specific type of tau — phosphorylated tau 217 — in the cerebrospinal fluid of pre-symptomatic subjects. If these primary and secondary endpoints are positive in analyses two years after the study begins, the trial will be extended by another two years to evaluate whether the drug slows cognitive decline and has further impact on tau pathology.
"As more and more evidence shows that the removal of amyloid plaques has biologically beneficial effects on amyloid and tau proteins, we believe that simultaneously targeting the pathology of Alzheimer's disease – amyloid plaques and tau tangles – can provideHighestThe chance of success," said the principal investigator at the University of Washington and director of DIAN-TU, Charles F. andJoanne KnightRandall J. Bateman, MD, Distinguished Professor of Neurology, stated.
Eisai's Anti-MTBR Tau Antibody E2814 Selected as the First Exploratory Therapy in the Groundbreaking Dominantly Inherited Alzheimer Network Trials Unit Tau NexGen’s Anti-Tau Drug, Initially Targeting Tau Protein. Increasing Evidence Shows That Removing Amyloid Plaques Can Slow Cognitive Decline, Creating New Possibilities for Potentially Combating This Devastating Disease.
"Eisai is proud that our exploratory anti-amyloid beta protofibril antibody, lecanemab, has been selected as the foundational anti-amyloid drug in this research field," said Lynn Kramer, MD, FAAN, Chief Clinical Officer of Eisai's Neurology Business. "In our...2bIn the study, lecanemab 10 mg/kg was administered once every two weeks without titration. It demonstrated effective clearance of amyloid plaques in the brain from the early stages of treatment and slowed cognitive decline in patients with early Alzheimer's disease (AD). Encouragingly, under the same dosage, the incidence of amyloid-related imaging abnormalities – edema/effusion was 9.9%, with less than 2% being symptomatic.
Eisai has positioned neurology as a key therapeutic area and will continue to innovate in the development of novel drugs based on cutting-edge neuroscience research, seeking to further help improve the welfare of individuals and their families affected by diseases with high unmet needs (such as dementia, including AD). Our vision is clear: a world without neurodegenerative diseases.