Eisai : Etalanetug Demonstrates Reduction Of EMTBR-tau243 In Phase Ib/II Alzheimer's Study

(RTTNews) - Eisai Co., Ltd. announced new data on its anti-tau antibody etalanetug at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference. Etalanetug is designed to bind to the microtubule-binding region (MTBR) of tau protein, aiming to prevent the seeding and propagation of tau pathology.

The presentation highlighted findings from the Phase Ib/II study (E2814-103), which involved seven individuals with dominantly inherited Alzheimer's disease (DIAD). In three of these participants, tau aggregates in the brain were measured using tau PET imaging. Results showed that tau PET signals were stabilized or trended toward a decrease following administration of etalanetug, suggesting that the therapy inhibited tau propagation and reduced the accumulation of tau aggregates.

The study also evaluated eMTBR-tau243, a novel biomarker of tau pathology progression, by measuring changes in cerebrospinal fluid (CSF) and plasma. MTBR-tau243 is a CSF biomarker correlated with tau pathology, while eMTBR-tau243 has been developed as a highly sensitive plasma biomarker.

eMTBR-tau243 consists of tau fragments that include amino acid residue 243 and MTBR, with endogenous cleavage at the C-terminal side of residue 256. It is believed to arise during the formation of neurofibrillary tangles, a key pathological feature of Alzheimer's disease. Strong correlations have been demonstrated between tau PET signals and eMTBR-tau243 levels in both plasma and CSF, making it possible to monitor tau pathology progression through a simple blood test.

Study results showed that etalanetug reduced CSF eMTBR-tau243 by 62% at three months and by 89% at nine months. Plasma eMTBR-tau243 was reduced by 78% at three months and by more than 90% at nine months. These findings support etalanetug's mechanism of action in inhibiting tau seeding and spreading in the brain, encouraging further research into its potential as a disease-modifying therapy for Alzheimer's disease.

Currently, etalanetug is being evaluated in two ongoing clinical studies: the Tau NexGen Phase II/III trial in DIAD, conducted under the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and led by Washington University School of Medicine in St. Louis, added to a standard-of-care anti-Ab protofibril antibody lecanemab (brand name: LEQEMBI), and the Phase II Study 202, a global randomized trial in individuals with early sporadic AD, also assessing etalanetug added to lecanemab as the standard of care.

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