Eisai and Biogen has infused capital into a dynamic Alzheimer’s disease focused collaboration showcasing the importance of industry, academic and industry collaborative enterprises.  TrialSite News strongly believes these types of dynamic, joint efforts represent a instrumental role in solving complex challenges in pursuit of ultimately offering new therapies.

The Alzheimer’s Clinical Trials Consortium (ACTC)  and Eisai Co., Ltd announced the investigational oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat and investigational anti-amyloid beta (Aβ) protofibril antibody BAN2401, which are currently being evaluated as treatments for early Alzheimer’s disease (AD), were selected by ACTC as treatments to be evaluated in upcoming clinical trials targeting primary prevention known as the “A3 Study” as well as secondary prevention known as the “A45 Study.” Funding originates from multiple sources including the National Institutes of Health and Eisai.

The ACTC is a National Institute of Aging (NIA)  funded clinical trial network with 35 primary clinical study sites across the United States. It aims to accelerate and expand studies targeting AD and related dementia across the spectrum from pre-symptomatic to more severe stages of the disease.  Established in 2017 with grant funding from NIA, its A3 and A45 studies are led by three academic principal investigators including:

  • Dr. Paul Aisen, University of Southern California
  • Dr. Reisa Speling, Brigham and Women’s Hospital & Massachusetts General Hospital, Harvard Medical School
  • Dr. Keith Johnson, Brigham and Women’s Hospital & Massachusetts General Hospital, Harvard Medical School

Dr. Sperling notes “the A3 and A45 studies should provide critically important answers about the optimal time to intervene with anti-amyloid therapy, with the hope that starting treatment much earlier in the disease process may be advantageous in preventing future cognitive decline.”

Lynn Kramer, MD,  Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai comments “we are excited to partner with the ACTC group with trials focusing on therapies for earlier stages of AD and will thus allow us to understand the benefit of BAN2401 and elenbecestat across a broad spectrum of disease.”

What is Elenbecestat?

Discovered by Japanese Eisai, it is an investigational next generation oral candidate for the treatment of AD that inhibits BACE. By inhibiting BACE, a key enzyme in the production of Aβ the investigational drug reduces Aβ  production, which reduces amyloid aggregates in the brain. Hence it may have the potential to slow the progression of AD.  It is currently being tested in the MISSION AD Phase 3 study program.

What is BAN2401

Discovered through a strategic research alliance between Eisai and Sweden-based BioArtic AB,  BAN2401 is a humanized monoclonal antibody for AD.  It selectively binds to neutralize and eliminate soluble, toxic  Aβ aggregates (protofibril) that may be a causal factor in AD.  It is currently being tested in the Phase 3 CLARITY AD  program.

Eisai and Biogen Collaboration

Both Eisai and Biogen Inc. are collaborating on the joint development and commercialization of AD treatments. The sponsor reports that trials will start in early 2020 and more information can be accessed via the study website.

 ACTC Background

Funded by the National Institute on Aging at the National Institutes of Health, it provides the infrastructure for academic clinical trials focusing on AD and related dementias. The consortium is based at the University of Southern California and includes Harvard University and the Mayo Clinic. It infuses collaborative energy and expertise into AD research and includes trial design, biostatistics, informatics, medical safety, regulatory oversight, patient recruitment, clinical operations, data management and site monitoring as well as biomarker laboratory and repository and neuroimaging. It includes 35 primary clinical sites across the United States. More can be gleaned from its website.

Source: Eisai

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