Update on the DIAN-TU-001 Trial with E2814 and Investigational Lecanemab (Eisai Co., Ltd)

September 28, 2022

The statement below is in response to the 28 September 2022 announcement found on Eisai’s website.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) announced positive topline results from the large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.

Eisai and the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis have previously announced a collaboration to include lecanemab in the DIAN-TU NexGen trial to be tested with  E2814 – an experimental immunotherapy targeting the microtubule binding domain of the tau protein. The positive results reported in the Clarity AD trial are highly impactful for the treatment of Alzheimer’s disease. “We are delighted about the report of beneficial effects in the Clarity Alzheimer’s disease trial and what this could mean for millions of Alzheimer’s disease patients,” said principal investigator Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology and the director of DIAN-TU.  “In our symptomatic and secondary prevention trials in dominantly inherited Alzheimer’s disease, all participants will receive lecanemab and in combination will be randomized to receive an anti-tau drug (E2814) or placebo.  We have scientific rationale that targeting both amyloid and tau could provide an even greater benefit than either alone.”

Because the Clarity AD trial was conducted in a non-dominantly inherited form of AD, it is possible that treatment benefits from lecanemab may be different in dominantly inherited AD (DIAD). The results of the Clarity AD trial support the investigational use of lecanemab in DIAD, and the DIAN-TU NexGen trial will continue with lecanemab as designed.  Safety data will continue to be monitored by the DIAN-TU Data Safety Monitoring Board.  The DIAN-TU NexGen trial of E2814 and lecanemab is currently recruiting participants [Clinicaltrials.gov NCT05269394].