EISAI TO PRESENT FULL FINDINGS FROM LECANEMAB CONFIRMATORY PHASE 3 CLINICAL TRIAL (CLARITY AD) AND OTHER ALZHEIMER’S DISEASE RESEARCH AT THE 15TH CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE

TOKYO, Nov. 20, 2022 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) will current the efficacy, security and biomarker findings from the corporate’s Phase 3 confirmatory Clarity AD medical trial for lecanemab (growth code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential remedy of delicate cognitive impairment (MCI) on account of Alzheimer’s illness (AD) and delicate AD (collectively often known as early AD) with confirmed presence of amyloid pathology within the mind, on the fifteenth Clinical Trials on Alzheimer’s Disease (CTAD) convention. At the assembly, which shall be held in San Francisco, CA and nearly from November 29 to December 2, Eisai and esteemed college will current the complete knowledge in a scientific session on the primary day of the assembly (November 29 at 4:50 p.m. PT). Additionally, different necessary analysis from the lecanemab medical growth program and Eisai’s AD pipeline, together with the corporate’s investigational anti-microtubule binding area (MTBR) tau antibody (E2814), shall be introduced in 4 oral and ten poster shows.

Topline outcomes from Clarity AD had been introduced in late September and confirmed that lecanemab met the first endpoint and all key secondary endpoints with extremely statistically important outcomes, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was inside expectations.

Key Eisai Lecanemab CTAD Presentations

• Clarity AD: Full outcomes from the Phase 3 confirmatory Clarity AD medical trial of lecanemab in sufferers with early AD shall be introduced in a scientific session on November 29 at 4:50 p.m. PT. Eisai will host a dwell webcast of shows within the session and will be seen dwell on the investors section of the Eisai Co., Ltd. web site.

• Aβ Protofibrils Binding Properties: Research finding out the characterization of Aβ protofibrils and the distinctive binding properties and mechanisms of Aβ clearance of lecanemab (Poster #P029)

• AHEAD 3-45 Study:

“Based on the Clarity AD outcomes, the investigational anti-amyloid beta protofibril antibody lecanemab has the potential to make a clinically significant distinction for folks dwelling with the early phases of Alzheimer’s illness and their households by slowing cognitive and useful decline,” mentioned Lynn Kramer, M.D., Chief Clinical Officer, Alzheimer’s Disease and Brain Health at Eisai Co., Ltd. “Eisai is happy to share the outcomes of the corporate’s confirmatory Phase 3 Clarity AD medical research at CTAD and current necessary knowledge exploring lecanemab’s potential efficacy, security and use in quite a lot of early AD affected person sub-populations.”

Eisai goals to file for conventional approval within the U.S. and for advertising authorization functions in Japan and Europe by the top of Eisai’s FY2022, which ends March 31, 2023. In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab below the accelerated approval pathway and granted it Priority Review. The Prescription Drug User Fee Act (PDUFA) motion date is January 6, 2023. The FDA has agreed that the outcomes of Clarity AD can function the confirmatory research to confirm the medical advantage of lecanemab. In an effort to safe conventional FDA approval for lecanemab as quickly as attainable, Eisai submitted the BLA by the FDA’s Accelerated Approval Pathway in order that the company might full its evaluation of all lecanemab knowledge aside from the information from the confirmatory Clarity AD research. In March 2022, Eisai started submitting software knowledge, aside from Clarity AD knowledge, to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) below the prior evaluation session system, with the intention of acquiring early approval for lecanemab so that folks dwelling with early AD might have entry to the remedy as quickly as attainable.

CTAD 2022 Presentations Relating to Eisai’s Key Compounds, Research and Collaborations

Oral Presentations

Poster Presentations

Sysmex Poster Presentation

Eisai serves because the lead of lecanemab growth and regulatory submissions globally, with each Eisai and Biogen co-commercializing and co-promoting the product and Eisai having ultimate decision-making authority.

This launch discusses investigational makes use of of brokers in growth and isn’t meant to convey conclusions about efficacy or security. There is not any assure that such investigational brokers will efficiently full medical growth or acquire well being authority approval.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@eisai.com

Eisai Europe, Ltd.
(Europe, Australia, New Zealand and Russia)
EMEA Communications Department
EMEA-comms@eisai.net

[Notes to editors]

1.  About Clarity AD

* CDR-SB is a numeric scale used to quantify the varied severity of signs of dementia. Based on interviews of individuals dwelling with AD and household/caregivers, certified healthcare professionals assess cognitive and useful efficiency in six areas: reminiscence, orientation, judgment and downside fixing, group affairs, dwelling and hobbies, and private care. The complete rating of the six areas is the rating of CDR-SB, and CDR-SB can also be used as an applicable merchandise for evaluating the effectiveness of therapeutic medication focusing on the early phases of AD.

** ADAS-cog is the most typical cognitive evaluation instrument utilized in AD medical trials all around the world. ADAS-cog14 consists of 14 competencies: phrase recall, instructions, constructional praxis, object and finger naming, ideational praxis, orientation, phrase recognition, remembering phrase recognition directions, comprehension of spoken language, phrase discovering problem, spoken language skill, delayed phrase recall, quantity cancellation and maze activity. ADAS-cog has been utilized in medical trials for earlier phases of AD together with MCI.

*** Developed by Eisai, ADCOMS combines gadgets from the ADAS-cog scale for assessing cognitive features, MMSE and the CDR scale for evaluating the severity of dementia to allow extremely delicate detection of adjustments in medical features of early AD signs and adjustments in reminiscence.

**** ADCS MCI-ADL assesses the competence of sufferers with MCI in actions of every day dwelling (ADLs), primarily based on 24 inquiries to the affected person’s accomplice about precise latest actions of every day dwelling.

2.  About Lecanemab (Development code: BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for AD that’s the results of a strategic analysis alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and remove soluble, poisonous amyloid-beta (Aβ) aggregates (protofibrils) which might be thought to contribute to the neurodegenerative course of in AD. As such, lecanemab might have the potential to affect illness pathology and to decelerate the development of the illness. Currently, lecanemab is being developed as the one anti-Aβ antibody that can be utilized for the remedy of early AD with out the necessity for titration.

In the worldwide Phase 3 confirmatory Clarity AD research, lecanemab remedy met the first endpoint and diminished medical decline on the worldwide cognitive and useful scale, CDR-SB, in contrast with placebo at 18 months by 27%, which represents a remedy distinction within the rating change of -0.45 (p=0.00005) within the evaluation of Intent-to-treat (ITT) inhabitants. Starting as early as six months, throughout all time factors, the remedy confirmed extremely statistically important adjustments in CDR-SB from baseline in comparison with placebo (all p-values are lower than 0.01). All key secondary endpoints had been additionally met with extremely statistically important outcomes in contrast with placebo (p<0.01). Key secondary endpoints had been the change from baseline at 18 months in contrast with placebo of remedy in amyloid ranges within the mind measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL). The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an hostile occasion related to anti-amyloid antibodies, was 12.5% within the lecanemab group and 1.7% within the placebo group. The incidence of symptomatic ARIA-E was 2.8% within the lecanemab group and 0.0% within the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) fee was 17.0% within the lecanemab group and eight.7% within the placebo group. The incidence of symptomatic ARIA-H was 0.7% within the lecanemab group and 0.2% within the placebo group. There was no imbalance in remoted ARIA-H (i.e., ARIA-H in sufferers who didn’t additionally expertise ARIA-E) between lecanemab (8.8%) and placebo (7.6%). The complete incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% within the lecanemab group and 9.3% within the placebo group. Overall, lecanemab’s ARIA incidence profile was inside expectations.

Since July 2020, the Phase 3 medical research (AHEAD 3-45) for people with preclinical AD, which means they’re clinically regular and have intermediate or elevated ranges of amyloid of their brains, is ongoing. AHEAD 3-45 is performed as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that gives the infrastructure for tutorial medical trials in AD and associated dementias within the U.S, funded by the National Institute on Aging, a part of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen medical research for Dominantly Inherited AD (DIAD), that’s performed by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and contains lecanemab because the spine anti-amyloid remedy together with E2814 MTBR-tau antibody or placebo.

Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 research.

3.  About E2814
An investigational anti-microtubule binding area (MTBR) tau antibody, E2814, is being developed as a disease-modifying agent for tauopathies together with sporadic AD. Phase I medical research are underway. E2814 was found as a part of the analysis collaboration between Eisai and University College London. E2814 is designed to forestall the spreading of tau seeds inside the brains of affected people. In addition, a Phase II/III Tau NexGen research for the remedy of dominantly inherited Alzheimer’s illness (DIAD), performed by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in St. Louis (St. Louis, MO, USA), is underway.

4.  About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint growth and commercialization of AD therapies since 2014. Eisai serves because the lead of lecanemab growth and regulatory submissions globally, with each corporations co-commercializing and co-promoting the product and Eisai having ultimate decision-making authority.

5.  About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration concerning the event and commercialization of AD therapies. Eisai obtained the worldwide rights to check, develop, manufacture and market lecanemab for the remedy of AD pursuant to an settlement with BioArctic in December 2007. The growth and commercialization settlement on the antibody lecanemab back-up was signed in May 2015.

6.  About the Collaboration between Eisai and Sysmex
Eisai and Sysmex entered right into a complete non-exclusive collaboration settlement aimed on the creation of latest diagnostics within the subject of dementia in February 2016. Leveraging one another’s applied sciences and information, the 2 corporations intention to find next-generation diagnostics that can allow early analysis, number of remedy choices and common monitoring of the consequences of remedy for dementia.

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SOURCE Eisai Inc.