etalanetug (E2814) / Eisai, University College London - LARVOL DELTA

Eisai Presents Latest Findings Showed Etalanetug Reduced Alzheimer’s Disease Tau Tangle-Specific Plasma Biomarker MTBR-tau243 at Alzheimer’s Association International Conference (AAIC) 2026 (Eisai Press Release) - "Etalanetug reduced CSF eMTBR-tau243 by 62% at three months and by 89% at nine months. Etalanetug reduced plasma eMTBR-tau243 by 78% at 3 months and by more than 90% at 9 months, indicating that plasma eMTBR-tau243 closely mirrored disease-related changes captured in CSF. Plasma phosphorylated tau (p-tau217, p-tau181, and p-tau231) and t-tau increased after etalanetug administration in both individuals with DIAD and healthy adults. This change is considered to be attributable to non-CNS tau species derived from peripheral tissues being stabilized by binding to etalanetug in plasma, thereby inhibiting their degradation."

Biomarker • P1/2 data • Alzheimer's Disease

A Surrogate Antibody Of Etalanetug, H25L15-hIgG1, Promotes Uptake Of Tau Monomer And Aggregate In Human Macrophages Through Fcγ Receptors (AAIC 2026) - No abstract available

Baseline Imaging Characteristics Of Participants In A Phase 2 Trial Of Etalanetug And Concurrent Lecanemab (AAIC 2026) - No abstract available

P2 data • Alzheimer's Disease • CNS Disorders

Etalanetug Reduces Tau Tangle Specific Plasma E-MTBR-tau243 In DIAD While Increasing Plasma P-tau And T-tau In Healthy And DIAD (AAIC 2026) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders

A Novel CSF EMTBR‑tau243 Immunoassay For Detecting AD Tau Pathology And Assessing Etalanetug Pharmacodynamics In DIAD (AAIC 2026) - No abstract available

PK/PD data

University College London (UCL) and Eisai...have signed a new agreement to extend their long-standing collaboration in drug discovery and development for five more years, taking the partnership through to 2030 (Eisai Press Release) - "One of the most notable outcomes of the UCL–Eisai collaboration to date is the anti-MTBR tau antibody E2814, which was first discovered as part of collaborative research between the two organisations....In total, eight drug discovery projects focusing on a variety of therapeutic targets have been supported through a £10 million investment to date, with further investment committed over the next five years as part of the extension."

Licensing / partnership • Alzheimer's Disease

A validated ligand binding assay for the determination of etalanetug, a novel anti-tau therapeutic antibody, in rats and monkeys for nonclinical pharmacokinetic studies. (PubMed, J Pharm Biomed Anal) - "Incurred sample reanalysis further confirmed assay reproducibility. These results support the suitability of the developed LBA for nonclinical PK studies of etalanetug in both rats and monkeys."

First-in-human • Journal • PK/PD data • Preclinical • Alzheimer's Disease • CNS Disorders

Etalanetug (E2814) in dominantly inherited Alzheimer's disease: an open-label phase 1b/2 study to assess safety and target engagement in participants with mild to moderate cognitive impairment. (PubMed, Alzheimers Res Ther) - P1/2 | "Etalanetug treatment in these symptomatic participants with DIAD was tolerated across dose levels, and immunogenicity was found to be minimal. Etalanetug demonstrated effects on both hyperphosphorylated tau and tau tangle pathology. Taken together, the data support continued evaluation of etalanetug as an AD disease-modifying therapy."

Journal • P1/2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

FROM CLINICAL TRIALS TO THE DISH: IPSC-DERIVED NEURONAL MODELS FOR PRECISION DRUG SCREENING IN AD, PD, AND TAUOPATHIES (ADPD 2026) - "The LumiSTAR tri-culture platform can also serve as a Tau aggregate clearance model for therapeutic validation, as demonstrated using clinical candidates such as MAPTRx (Tau antisense oligonucleotide) and E2814 (Tau monoclonal antibody)... LumiSTAR establishes a robust high-throughput discovery platform with automated signal detection, high-content imaging, and robotic handling that dramatically reduces manual variability — and has already validated with multiple FDA-approved antibody therapeutics for AD/PD. This system provides a translational and scalable preclinical platform that enables precision drug validation, repurposing, and de novo therapeutic discovery for neurodegenerative disease."

Clinical • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2

CROSSING MOLECULAR BOUNDARIES: AN IMMUNOTHERAPEUTIC SIMULTANEOUSLY TARGETING AMYLOID-Β, TAU, AND Α-SYNUCLEIN AMYLOID AGGREGATES (ADPD 2026) - "Lecanemab, Etalanetug, and Prasinezumab biosimilars served as benchmarks. Amyl-2 has nanomolar affinity for amyloid aggregates, inhibits aggregation across Aβ, Tau, and α-synuclein, and promotes robust phagocytic clearance of amyloid aggregates. Amyl-2 presents a strong potential to act as a disease-modifying therapeutic across amyloid-driven neurodegenerative diseases. Ongoing optimization to enhance binding affinities, improve brain permeability and mitigate amyloid-related imaging abnormalities (ARIA) strengthens the translational promise of this platform technology for AD, PD, and other amyloid-mediated diseases."

Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=438 | Active, not recruiting | Sponsor: Washington University School of Medicine | N=210 ➔ 438 | Trial primary completion date: Sep 2019 ➔ Sep 2023

Biomarker • Enrollment change • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2016 ➔ Mar 2017

Biomarker • Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=438 | Recruiting | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Recruiting

Biomarker • Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jul 2022 ➔ Oct 2027 | Trial primary completion date: Jul 2022 ➔ Oct 2027

Biomarker • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Recruiting | Sponsor: Washington University School of Medicine | Completed ➔ Recruiting | N=194 ➔ 490 | Trial completion date: Mar 2020 ➔ Jul 2022 | Trial primary completion date: Nov 2019 ➔ Jul 2022

Biomarker • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Oct 2027 ➔ Jul 2028 | Trial primary completion date: Oct 2027 ➔ Apr 2028

Biomarker • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=194 | Completed | Sponsor: Washington University School of Medicine | Recruiting ➔ Completed | N=490 ➔ 194 | Trial completion date: Mar 2021 ➔ Mar 2020 | Trial primary completion date: Dec 2020 ➔ Nov 2019

Biomarker • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=210 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Recruiting | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Recruiting

Biomarker • Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=438 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Washington University School of Medicine | Trial primary completion date: Jan 2017 ➔ Sep 2019

Biomarker • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Washington University School of Medicine

Biomarker • New P2/3 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 (clinicaltrials.gov) - P2/3 | N=490 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2023 ➔ Mar 2021 | Trial primary completion date: Sep 2023 ➔ Dec 2020

Biomarker • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia