#Japan #Tokyo #Eisai #Alzheimer's #Etalanetug

Eisai Secures Fast Track Designation for Etalanetug

In a significant development in Alzheimer's disease research, Eisai Co., Ltd., headquartered in Tokyo and led by CEO Haruo Naito, has announced that its investigational drug etalanetug (development code: E2814) has received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is a part of the FDA’s initiative to streamline the development process for new medications that address pressing medical needs, particularly those that treat serious conditions like Alzheimer's disease.

Alzheimer's disease, characterized by chronic neurodegeneration, is primarily marked by the buildup of protein deposits in the brain. These include amyloid-beta plaques and neurofibrillary tangles composed of tau protein. Recent studies have highlighted the roles of these protein aggregates in driving the neurodegenerative process that leads to cognitive decline.

Etalanetug is particularly notable as it targets specific tau species that contain the microtubule binding region (MTBR). This antibody is designed to interfere with tau pathologies, especially as they propagate across different regions of the brain. The discovery of etalanetug stems from a research partnership between Eisai and University College London, emphasizing strong collaborative efforts in neuroscience research.

The initial Phase I/II clinical trial (Study 103, NCT04971733) evaluated etalanetug in patients with Dominantly Inherited Alzheimer's Disease (DIAD). Results indicated that etalanetug effectively engaged MTBR-tau species in cerebrospinal fluid, confirmed via significant reduction of CSF MTBR-tau243—a biomarker associated with tau pathology in the brain. Moreover, there was a noted trend towards a decrease in tau PET signal, suggesting that etalanetug may successfully inhibit the spread of tau pathology and accumulation of these harmful aggregates in DIAD patients.

Eisai is currently advancing the clinical evaluation of etalanetug in combination with an anti-amyloid β protofibril antibody, lecanemab, in two pivotal trials. The Tau NexGen Phase II/III clinical trial (NCT05269394) is being led by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University School of Medicine in St. Louis, alongside another Phase II trial (Study 202, NCT06602258) aimed at patients with early sporadic Alzheimer's disease.

The ongoing exploration into tau-targeting treatments like etalanetug signifies a promising addition to Alzheimer's therapeutic options. Following the focus on amyloid beta, the development of tau-modifying treatments may represent a breakthrough, enhancing the landscape of Alzheimer’s disease management and offering hope for improved patient outcomes.

Eisai prioritizes neurology as a critical therapeutic area, remaining committed to pioneering advancements in drug development stemming from cutting-edge research. The company aims to create impactful innovations that can benefit individuals and families grappling with diseases associated with high unmet needs, such as dementia and Alzheimer's disease.