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Research Report
E-2814: A Comprehensive Review of an Investigational Anti-Tau Antibody for Alzheimer's Disease
Abstract
E-2814 (Etalanetug) is an investigational humanized monoclonal IgG1 antibody developed by Eisai Co., Ltd., in collaboration with University College London, targeting the microtubile binding region (MTBR) of the tau protein. Its mechanism involves binding to the HVPGG epitope within the MTBR, aiming to inhibit tau seeding, prevent cell-to-cell propagation of pathogenic tau species, and facilitate their microglial clearance, thereby addressing a core neuropathology of Alzheimer's Disease (AD). Clinical development has progressed through Phase 1 studies in healthy volunteers and Phase 1b/2 studies in patients with Dominantly Inherited Alzheimer's Disease (DIAD). These early trials have demonstrated a generally manageable safety profile and evidence of central nervous system target engagement, with a CSF-to-serum ratio of approximately 0.2%. Pharmacodynamic studies in DIAD patients have shown significant reductions in CSF biomarkers of tau pathology, including MTBR-tau243 and p-tau217, and trends towards stabilization or reduction in tau PET signal, effects not observed in healthy volunteers, suggesting disease-specific activity. E-2814 is currently being evaluated in larger Phase 2/3 trials, notably the Tau NexGen study (NCT05269394) in DIAD and a Phase 2 study (NCT06602258) in sporadic early AD, often in combination with the anti-amyloid antibody lecanemab. These ongoing studies are critical for determining the clinical efficacy of E-2814 in slowing cognitive decline and further characterizing its long-term safety. The development program reflects a strategy of leveraging insights from DIAD to inform sporadic AD research and exploring combination therapies targeting multiple AD pathologies.
1. Introduction to E-2814
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2024/09/19 | Phase 2 | Active, not recruiting | |||
2022/03/08 | Phase 2 | Active, not recruiting | |||
2021/07/21 | Phase 1 | Completed | |||
2020/01/18 | Phase 1 | Completed | |||
2013/01/03 | Phase 2 | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
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