WOODCLIFF LAKE, N.J., July 22, 2021 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the presentation of findings from the company's robust Alzheimer's disease (AD) pipeline, including lecanemab (BAN2401). Recently granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA), lecanemab is an investigational humanized monoclonal antibody that binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. Data and research from Eisai's rich dementia pipeline, including joint assets with Biogen, will be featured in 18 oral and poster presentations at the 2021 Alzheimer's Association International Conference (AAIC), July 26-30, 2021 in Denver, Colorado and virtually.

• A lecanemab late-breaker oral presentation will report a preliminary assessment of the investigational compound's clinical effects from the open label extension phase 2 proof of concept study in early AD.
• Eisai's Deputy Chief Clinical Officer Michael Irizarry, M.D., MPH will present findings from an evaluation of the longitudinal plasma Aβ 42:40 ratio and the relationship to longitudinal brain amyloid PET SUVr in the core and open label extension of the Phase 2 proof of concept study following treatment with lecanemab in subjects with early AD.
• Another oral presentation will feature preliminary screening and baseline characteristics of the lecanemab Phase 3 clinical AHEAD 3-45 study for preclinical AD.

"The lecanemab data and information Eisai and Biogen will present at AAIC 2021 is particularly relevant given that the U.S. Food and Drug Administration recently granted lecanemab Breakthrough Therapy designation," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "The momentum behind Eisai's growing Alzheimer's disease franchise and the accelerated approval of Eisai and Biogen's ADUHELM is exciting. In March 2021, Eisai and Biogen completed enrollment of 1,795 patients with early Alzheimer's disease in our Phase 3 Clarity AD clinical study and the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical Alzheimer's disease."

• An oral presentation regarding the clinical study design of the Dominantly Inherited AD (DIAD) Trial of Eisai's investigational MTBR (microtubule binding region) targeted anti-tau antibody E2814 will be given. E2814 was selected by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) as the first investigational medicine among anti-tau drugs for the DIAN-TU tau study.

• A poster presentation will be given on the results of in vivo study of E2511, Eisai's investigational novel synapse re-generating small compound tropomyosin receptor kinase A (TrkA) allosteric modulator.

• Biogen Inc. will make five presentations about our joint asset ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection, including an oral presentation about the design of ICARE AD-US, a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in the US.
   
  ADUHELM was granted accelerated approval by the US FDA on June 7, 2021. ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in Aβ plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Please see full Prescribing Information, including the Medication Guide. 

"Alzheimer's disease is a progressively debilitating and devastating neurodegenerative disease. The focus on Alzheimer's disease has historically been on alleviating cognitive and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease through the science of biomarkers. At Eisai, our goal is to serve patients by transforming the current symptom-based framework to one where biomarkers become a core component of diagnosis, prognosis and therapeutic decision-making," said Harald Hampel, M.D., Ph.D., Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc. "We look forward to sharing data and discussing the scientific rationale that the amyloid-beta pathway plays a key role in the pathophysiology of Alzheimer's disease."

Virtual Symposium

Eisai and Biogen will hold a virtual symposium, "Defining the next-generation clinical care pathway for Alzheimer's disease: biological, technological, and healthcare perspectives." As the AD treatment landscape evolves, it is critical to transform the AD patient journey from a symptoms-based approach to a next-generation biomarker-guided and technology-enabled clinical care pathway. Esteemed faculty will review the latest advances and challenges in the integration of in vivo biomarkers and emerging digital tools into the larger healthcare ecosystem for AD. Featured speakers will include:

• Jeffrey Cummings, MD, ScD
• Wiesje van der Flier, PhD
• Rhoda Au, PhD, MBA
• Soeren Mattke, MD, DSc

The symposium will be held in-person and virtually Monday, July 26, 2021, 11:30 a.m. - 12:45 p.m. Mountain Daylight Time and will be available online 30 days following AAIC 2021. Onsite attendees may participate live at the Colorado Ballroom in the Hilton Denver City Center.

Below please find a list of important presentations and symposia at this year's meeting. All presentations will be available online to registered participants via the AAIC virtual platform.

AAIC 2021 Presentations Relating to Eisai's Compounds and Research

Eisai and Biogen Symposium

Biogen Abstract Presentations for Alzheimer's Disease

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

What is the most important information a patient should know about ADUHELM?
ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or "ARIA". ARIA is a common side effect that does not usually cause any symptoms but can be serious. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling. Although most people with swelling in areas of the brain do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes, and nausea. The patient's healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. Patients should call their healthcare provider or go to the nearest hospital emergency room right away if they have any of the symptoms listed above.

Before receiving ADUHELM, patients should tell their healthcare provider about all of their medical conditions, including if: they are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. It is not known if ADUHELM will harm their unborn baby or if aducanumab-avwa (the active ingredient in ADUHELM) passes into breast milk.

What are the possible side effects of ADUHELM? ADUHELM can cause serious side effects, including: See above "What is the most important information a patient should know about ADUHELM? Serious allergic reactions. Swelling of the face, lips, mouth, or tongue and hives have happened during an ADUHELM infusion. Patients should tell their healthcare provider if they have any of the symptoms of a serious allergic reaction during or after an ADUHELM infusion.

The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA); headache and fall. Patients should call their healthcare provider for medical advice about side effects. Patients may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information including Medication Guide. 

[Notes to editors]

1. About Lecanemab (BAN2401)
   Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017. Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). In July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, was initiated. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai.
    
2. About the Joint Development between Eisai and Biogen for Alzheimer's Disease
   Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab.
    
3. About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
   Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.
    
4. About E2814
   An investigational anti-tau antibody, E2814 is being developed as a potential disease-modifying agent for tauopathies including sporadic AD. Phase I clinical studies are underway. E2814 was discovered as part of the research collaboration between Eisai and University College London. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.
    
5. About E2511
   E2511 is Eisai's in-house discovered and developed investigational novel molecule that directly binds to tropomyosin receptor kinase A (TrkA); a nerve growth factor (NGF) located on the neural cell membrane. E2511 could potentially promote recovery and synaptic remodeling of damaged cholinergic neurons. A Phase 1 study for E2511 is underway.
    
6. About Eisai Inc.
   At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

Contact:

Eisai Inc.
Libby Holman
201-753-1945
libby_holman@eisai.com 

SOURCE Eisai Inc.