Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study). The study will assess the effect of Eisai’s investigational anti-microtubule binding region (MTBR) tau antibody E2814, in dominantly inherited Alzheimer’s disease (DIAD).
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People who have genetic mutations of DIAD are known to develop Alzheimer’s disease (AD) and will likely develop symptoms at around the same age their affected parents did, often in their 50s, 40s or even 30s. The major AD pathologies are amyloid plaque that consists of amyloid beta (Aβ) aggregates; neurofibrillary tangles; and intraneuronal aggregates of tau, all of which are believed to spread throughout the brain.
The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in pre-symptomatic or symptomatic participants who have an Alzheimer’s disease-causing gene mutation. In March 2021, the DIAN-TU selected E2814, which was created from a research collaboration between Eisai and University College London, as the first investigational medicine among anti-tau drugs for the Tau NexGen study. With increasing evidence from clinical studies showing that targeting amyloid can reduce biomarkers of AD, the Tau NexGen clinical trial leaders selected Eisai’s investigational anti-Aβ protofibril antibody lecanemab as the background anti-amyloid therapy, and the study design was amended in November 2021.
Eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of novel medicines based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of affected individuals and their families in diseases with high unmet needs, such as dementia including AD.
About Dominantly Inherited Alzheimer Network (DIAN)
The DIAN is an international research effort focused on dominantly inherited Alzheimer’s disease. Dominantly Inherited Alzheimer’s disease (DIAD) is a rare form of AD that causes memory loss and dementia in individuals — typically while they are in their 30s to 50s. The disease affects less than 1% of the total population of people with Alzheimer’s. The aim of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) is to find solutions to treat or prevent this disease and, potentially, all forms of Alzheimer’s. The DIAN-TU is an international public-private partnership dedicated to designing and managing interventional therapeutic trials for individuals with and at risk of DIAD.
About Tau NexGen study
The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in people who have an Alzheimer’s disease-causing gene mutation. In the Tau NexGen study, symptomatic participants will be administered lecanemab for six months before being randomly assigned to also receive the anti-tau drug or a placebo. Since amyloid plaques accumulate before tau tangles in AD, this study design allows the researchers to assess whether amyloid removal clears the way for the anti-tau drug to function most effectively.