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HIROSHIMA, Japan, Oct 31, 2024 - (JCN Newswire via SeaPRwire.com) - Mazda Motor Corporation today launched a redesigned corporate website. Amid growing awareness and interest in sustainability, the company redesigned its website to provide stakeholders visiting the corporate website with more timely and user-friendly access to financial and non-financial data as well as information about initiatives set to enhance both corporate and social value.Within the corporate website, it also set up MAZDA MIRAI BASE, a new owned-media platform filled with videos and photos, to share stories about Mazda’s work to build a better future.Mazda Motor Corporation Website URL:Japanese - www.mazda.com/ja/English　-　www.mazda.com/en/MAZDA MIRAI BASE URL:Japanese　- www.mazda.com/ja/mazda-mirai-base/English - www.mazda.com/en/mazda-mirai-base/Key ImprovementsMazda’s website that presents the company’s worldview more clearly offering enhanced usabilityTo help our stakeholders quickly find information they need and access a broader range of corporate data, Mazda redesigned its website structure and reorganized the information posted. In addition, the content was optimized to convey Mazda’s corporate philosophy, established last year, and value creation approach, arranging these in a restructured corporate website that articulates our worldview seeking to create a vibrant future.New MAZDA MIRAI BASE platformThis new owned-media platform MAZDA MIRAI BASE has been created to share Mazda’s aspirations and initiatives for realizing its corporate philosophy and 2030 Vision. Working from the concept of a “media platform that connects with partners to create an exciting future,” MAZDA MIRAI BASE distributes articles, video and photos to tell stories about ”creating the joy of living” found in manufacturing safe and reliable automobiles, manufacturing sustainably, and creating moving experiences.Mazda will continue to pursue the ‘Joy of Driving’ under its core value “Human Centric,” and aim to deliver the ‘Joy of Living’ by creating moving experiences in customers' daily lives.Reference:Mazda’s Corporate Philosophy- Japanese　https://www.mazda.com/ja/about/philosophy/- English　　https://www.mazda.com/en/about/philosophy/ Copyright 2024 JCN Newswire via SeaPRwire.com.

Toyota City, Japan, Oct 31, 2024 - (JCN Newswire via SeaPRwire.com) - Today, Toyota Motor Corporation (hereafter, Toyota) and Nippon Telegraph and Telephone Corporation (hereafter, NTT) have agreed to a joint initiative in the field of mobility and AI/telecommunications with the aim of realizing a society with zero traffic accidents.Through their previous collaborations, the two companies have confirmed that they share common values, such as contributing to society through technological and industrial development, a people-centered approach, and global contributions that start in Japan. This time, they will further deepen their collaboration with the aim of achieving a "society with zero traffic accidents" as the first step towards realizing a prosperous mobility society where safety and freedom are in harmony.In order to achieve a society with zero traffic accidents, it is necessary to take an infrastructure-cooperative approach that constantly connects people, mobility and infrastructure, in addition to the advancement of driving support technology based on data-driven technology in cars and the development of future automated driving technology.To achieve both of these things, Toyota is developing Software Defined Vehicles (SDV) with safety and security as the top priority. Alongside the evolution of SDV, it will become more important to build infrastructure such as a high-speed, high-quality communication infrastructure, an AI infrastructure that can collect and intelligently process vast amounts of information, and a computing infrastructure.In this collaboration, NTT, whose strengths lie in the telecommunications, and Toyota will jointly build a "Mobility AI Platform" that combines a seamless communications infrastructure with AI and computing platforms that can intelligently process large amounts of data. By doing so, they aim to connect people, mobility, and infrastructure to realize a safe, secure, and sustainable mobility society with no traffic accidents.Details of the joint initiativeWe will jointly develop and operate the "Mobility AI Platform" and use it in our efforts(1) to achieve a society with zero traffic accidents. The Mobility AI Platform is made up of multiple elements(2).The Mobility AI Platform aims to standardize the mobility field, and we envision that it will be used not only by the two companies, but also by a wide range of industry, government, and academic partners who share the goal of realizing a society with zero traffic accidents.Through this initiative, the two companies expect to invest a total of 500 billion yen by 2030. Starting in 2025, they will begin development of the Mobility AI Platform, and from around 2028 under the three-pronged infrastructure, they will begin social implementation and collaboration with various partners, aiming for widespread adoption from 2030 onwards.(1) Main initiatives aimed at achieving a society with zero traffic accidents- Three-pronged infrastructure collaboration" to prevent collisions at blind intersections, etc.- Development of advanced driving support/future automated driving systems" that are data-driven, with AI learning on its own based on large amounts of driving data(2) Elements that make up the mobility AI platform1. Distributed computing platform (data center)Computing resources (data centers) for analyzing and processing vast amounts of data using AI are installed in distributed locations, utilizing IOWN's optical communication technology. By locating them in areas rich in renewable energy, we can achieve local production for local consumption of electricity, and by achieving high power efficiency in the coordination and processing of distributed computing resources and AI, we can promote the greening of the vast amounts of electricity needed for data analysis and processing.2. Intelligent communication infrastructureA system is being built to coordinate human mobility infrastructure through seamless communication that is suitable for various traffic environments and conditions in urban areas, rural areas, and suburbs. In addition to being highly reliable, it also achieves low-latency communication for large volumes of data.3. AI infrastructureA platform that achieves mobility AI that learns and infers from various data from human mobility infrastructure, based on a "distributed computing infrastructure (data center)" and "intelligent communication infrastructure". Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Oct 31, 2024 - (JCN Newswire via SeaPRwire.com) - Mitsubishi Motors Corporation (hereafter, Mitsubishi Motors) announced that the all-new Triton has been selected as a golden award winner at the VMARK Vietnam Design Awards 2024 in the Best Transportation Design category. This marks the second time that Mitsubishi Motors has won the award, after the Xforce topped the same category in 2023.Established in 2018, the VMARK Vietnam Design Awards is organized by the VDAS Design Association based in Ho Chi Minh City. This year, a jury of 42 internationally renowned design practitioners evaluated design projects from Vietnam and around the world, and each entry was evaluated against the five criteria of innovativeness, eco-friendliness, identity, functionality, and community. The most outstanding designs received the golden award, and this year, 19 projects were selected as gold award winners out of a total of 700 entries.The Triton is Mitsubishi Motors' one-ton pickup truck that traces its roots back to the Forte originally released in 1978. In the 45 years since, this global strategic vehicle from Mitsubishi Motors has sold a cumulative total of approximately 5.7 million units in approximately 150 countries spanning five generations of models. Developed under the product concept of "Power for Adventure," the all-new Triton features a complete overhaul of everything from the interior and exterior design to the chassis, ladder frame and engine, and more. It was first launched in Thailand – where its production site is located – in July 2023 and introduced in Japan in February 2024. The all-new Triton is being rolled out sequentially in 100 countries worldwide.In attending the VMARK Vietnam Design Award 2024 ceremony, Kazuhiro Watanabe, Division General Manager of Sales & Marketing Division, Mitsubishi Motors Vietnam Co., Ltd., commented: “This award is a testament to our 30-year journey of 'Drive ahead together for everyday Adventure' in Vietnam. The all-new Triton embodies this commitment by delivering exceptional quality, innovation, and a driving experience that resonates with the adventurous spirit of the Vietnamese people.”Norihiko Yoshimine, Product Design Director, Mitsubishi Motors, who designed the Triton, cheerfully commented, “The Triton expresses the majestic aura that is distinctively Mitsubishi, possessing both robustness and agility in addition to the toughness and sheer power expected of a pickup truck. Following in the footsteps of the award for the Xforce last year, I am deeply honored that the all-new Triton has earned such high recognition at the VMARK Vietnam Design Awards this year. This award will provide a boost, but we will also continue doing our utmost to promote the Triton’s appeal to even more customers in Vietnam.”VMARK Vietnam Design Awards 2024 Awards Page (only available in English and Vietnamese) https://www.vietnamdesignweek.org/vmark-vietnam-design-week-2024About Mitsubishi MotorsMitsubishi Motors Corporation (TSE:7211) — a member of the Alliance with Renault and Nissan — is a global automobile company based in Tokyo, Japan, which has about 28,000 employees and a global footprint with production facilities in Japan and the ASEAN region. Mitsubishi Motors has a competitive edge in SUVs, pickup trucks and plug-in hybrid electric vehicles, and appeals to ambitious drivers willing to challenge convention and embrace innovation. Since the production of our first vehicle more than a century ago, Mitsubishi Motors has been a leader in electrification — launched the i-MiEV, the world’s first mass-produced electric vehicle in 2009, followed by the Outlander PHEV, the world’s first plug-in hybrid electric SUV in 2013. With a target of increasing the sales ratio of electrified vehicles to 100% by 2035, Mitsubishi Motors will deliver models that embody Mitsubishi Motors-ness and contribute to the realization of a carbon-neutral society.For more information on Mitsubishi Motors, please visit the company's website athttps://www.mitsubishi-motors.com/en/ Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO and CAMBRIDGE, Mass., Oct 31, 2024 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. and Biogen Inc.  announced today that the latest findings for lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer’s disease (AD), were presented at the Clinical Trials for Alzheimer's Disease Conference (CTAD), held in Madrid, Spain, and virtually.Benefits of Continued Treatment with Lecanemab for People with Early ADIn July 2024 at the Alzheimer's Association International Conference (AAIC) 2024, results from the open-label long-term extension study (OLE) following the core study of the lecanemab Phase 3 Clarity AD study were presented, showing that the mean change from baseline in CDR-SB (global cognitive and functional scale) in the lecanemab treated group relative to the placebo group was -0.45 at 18 months, and at 36 months, this expanded to -0.95 compared to a prespecified natural history** cohort of AD. There was a 30% reduction in the relative risk of progressing to the next disease stage In addition, the tau PET substudy of the lecanemab Phase 3 Clarity AD clinical study showed that with three (3) years of continuous treatment with lecanemab, 59% of patients with no or low tau accumulation in the brain (no tau/low tau) at baseline showed improvement or no decline, and 51% showed improvement from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale.1Clarity AD data presented at CTAD expand on these initial results to include additional measurements resulting from three (3) years of continuous lecanemab treatment in patients with low levels of amyloid accumulation in the brain at baseline (less than 60 Centiloids: low amyloid). These data show that 46% of patients improved or had no decline, and 33% showed improvement from baseline on the CDR-SB. On the ADAS-Cog14 measurement scale, 46% of patients showed improvement or no decline and 43% showed improvement. On the ADCS MCI-ADL, 51% of patients showed improvement or no decline and 48% showed improvement. These results – from no tau/low tau population and low amyloid populations – suggest that earlier initiation of lecanemab treatment may have a positive impact on disease progression of early AD patients and may provide continued benefits to patients with early AD over the long term.2No new safety findings were observed with continued lecanemab treatment over three (3) years. Most amyloid-related imaging abnormalities (ARIA) occurred in the first six (6) months of treatment. After the first six (6) months, ARIA rates were low and similar to ARIA rates on placebo during the placebo- controlled period. With regards to the incidence of ARIA by ApoEε4 status during the continuous treatment, the incidence was higher in ApoE4 homozygotes than in heterozygotes or non-carriers, but rates of new ARIA were decreased after the completion of the 18 months core study as treatment continued, regardless of ApoEε4 status.2Correlation between Protofibrils and Biomarkers for Neurodegenerative Disease in the AD Brain Dual-acting lecanemab is the only early AD treatment available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain. Protofibrils accumulate early in the AD brain and lead to nerve cell function loss, abnormal nerve processes, inflammation, and memory loss. In non-clinical studies, antibodies against protofibrils prevented protofibril-mediated neuronal dysfunction and memory loss.Accurately quantifying the amount of protofibrils in human cerebrospinal fluid (CSF) has been challenging due to their low concentration. As such, a new measurement method was developed by researchers at Eisai to accurately quantify protofibrils in CSF.Utilizing this new method of measurement, the amount of protofibrils in AD CSF correlated more strongly with neurodegenerative disease biomarkers (CSF total tau and neurogranin) than with CSF Aβ42, a biomarker associated with Aβ plaques accumulation, indicating that protofibrils are closely related to synaptic dysfunction. Furthermore, it was observed that protofibrils, unlike plaques, are diffusible. These results suggest that protofibrils induce synaptic dysfunction, playing an important role in neurodegeneration in AD brains.3Lecanemab Treatment for Early AD: Insights from Long-Term U.S. Clinical StudiesDr. Marwan Noel Sabbagh, Moreno Family Chair for Alzheimer's Research and Vice Chairman for Research and Professor, Department of Neurology, Barrow Neurological Institute, presented outcomes of an analysis of the use of lecanemab treatment between January 6, 2023, and July 30, 2024, based on payment claims data from the Komodo Research Database, a medical database in the U.S. In the U.S., lecanemab is used in accordance with the US FDA-approved indication, dosing, and monitoring guidelines. The analysis found that access to lecanemab treatment is expanding and highlighted opportunities to improve access in rural areas and educational outreach for underserved populations.4Dr. David Watson of the Alzheimer's Research and Treatment Center reported on patients who continued to receive lecanemab treatment following the Phase II Study 201 and Phase III Clarity AD study. A total of 136 patients participated in both studies at this center, and 66 patients chose to continue lecanemab therapy, with 13 patients receiving treatment for more than five (5) years and 40 patients receiving treatment for more than three (3) years. More than half of the patients (15/24) who continued treatment with lecanemab for more than three (3) years after the core phase remained in their initial stage of disease. Further, in a survey of 11 patients (or their caregivers) who received lecanemab treatment for more than five (5) years, all patients responded that they were “very satisfied” or “satisfied” with lecanemab treatment. In addition, between 45% and 73% of patients responded that lecanemab treatment made them feel more positive about their daily life, social activities, memory, etc. "frequently" or "very often."5No new long-term safety findings were observed in these multi-year studies.5Progress in the AHEAD 3-45 Study: Improving Screening Eligibility Using Blood Biomarkers and Completing Patient EnrollmentAHEAD 3-45 is a Phase 3 clinical study for individuals with preclinical AD, meaning they are clinically unimpaired but have intermediate or elevated levels of amyloid in their brains. In the study, blood tests, cognitive function tests (PACC-5***), amyloid PET, MRI, and tau PET were used for screening. Based on the amount of Aβ accumulation in the brain as determined by amyloid PET, subjects were assigned to two (2) trials with different dose settings: the A3 trial, for those with borderline Aβ levels in the brain, and the A45 trial, for those with positive Aβ levels in the brain.6Screening with blood biomarker tests was important to improve eligibility for amyloid PET testing in subjects without cognitive impairment. Using plasma Aβ42/40 ratio and p-tau217/tau217 ratio in theinitial screening reduced screening failure on amyloid PET from more than 70% to less than 30%. In particular, plasma p-tau217 was shown to correlate with amyloid PET, supporting its role as a useful blood biomarker to identify elevated amyloid in the brain.6Enrollment for the AHEAD 3-45 study was completed in October 2024.Lifetime Achievement Award Presented to Professor LannfeltProfessor Emeritus Lars Lannfelt of Uppsala University received the CTAD Lifetime Achievement Award in recognition of his pioneering work in scientific discovery and drug development in AD. As part of this award ceremony, he delivered a keynote speech outlining the discovery of the arctic mutation in familial AD, its application to therapeutic strategies targeting protofibrils for AD treatment, and the development of lecanemab.Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision- making authority.*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline of this progressive, debilitating condition.7 Protofibrils cause injury to neurons in the brain which, in turn, can negatively impact cognitive function through multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.8**ADNI is a clinical research project launched in 2005 to develop methods to predict the onset of AD and to confirm the effectiveness of treatments. The ADNI observational cohort was pre-specified and used during the design of Clarity AD. The cohort represents the exact population of those in Clarity AD study; matched ADNI participants show similar degree of decline to placebo group out to 18 months.***PACC-5 is a composite measure that provides a highly sensitive measure of changes in cognitive function in individuals with preclinical AD.About lecanemab (LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and Great Britain. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union (EU).LEQEMBI’s approvals in these countries were based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.9,10 The mean CDR- SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In July 2024 Eisai presented 36-month data from the Phase 3 Clarity AD Open-Label Extension Study demonstrating that LEQEMBI-treated patients continued to show benefit at 36 months of treatment. In the 18-month core study of Clarity AD, there was a statistically significant difference in global cognition and function as measured by CDR-SB between the LEQEMBI and placebo groups. The separation in CDR-SB between the group that continued to receive LEQEMBI (early start group) and the group who switched from placebo to LEQEMBI (delayed start group) was maintained during the 6-month OLE following the core study. This indicates that similar disease trajectory for both early and delayed start groups occurred with LEQEMBI administration. The blood biomarker results (plasma Aβ42/40 ratio, ptau181, GFAP and NfL) showed improvement even after delayed initiation of treatment with LEQEMBI.Since 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, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti- amyloid therapy.About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.About the Collaboration between Eisai and BioArctic for ADSince 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody back-up was signed in May 2015.About Eisai Co., Ltd.Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.References:(1) Sperling, R., Selkoe, D., Reyderman, L., Youfang, C., Van Dyck, C. (2024, July 28 - August 1). Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease? [Perspectives Session] Alzheimer's Association International Conference, Philadelphia, PA, United States.(2) Van Dyck, C. (2024, October 29-November 1). Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease? [Symposium on Lecanemab Continued Dosing] Clinical Trials for Alzheimer's Disease, Madrid, Spain.(3) De Simone, F., Buitrago, L., Benina, N., et al. (2024, October 29-November 1). The use of plasma biomarkers for the prediction of Amyloid positivity. [Oral Presentation] Clinical Trials for Alzheimer’s Disease, Madrid, Spain.(4) Sabbagh, M., Zhao, C., Mahendran, M. et al. (2024, October 29-November 1). Lecanemab Treatment in Real World Settings in the United States. [Late Breaking Symposium 2]. Clinical Trials for Alzheimer's Disease, Madrid, Spain.(5) Watson, D., Neam, M., Stafford, M. et al. (2024, October 29-November 1). Transitioning from Clinical Trial to Clinical Practice for Long-Term Lecanemab Treatment in Early Alzheimer's Disease: Perspectives from an Alzheimer's Disease Treatment Center. [Poster Presentation]. Clinical Trials for Alzheimer's Disease, Madrid, Spain.(6) Sperling, RA., Rissman, R., Johnson, KA., et al. (2024, October 29-November 1). Screening Plasma Biomarkers, Amyloid and Tau PET Imaging in the AHEAD 3-5 Study. [Late Breaking Symposium 1]. Clinical Trials for Alzheimer's Disease, Madrid, Spain.(7) Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z(8) Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.(9) Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer's disease at Clinical Trials on Alzheimer's Disease (CTAD) conference. Available at: www.eisai.com/news/2022/news202285.html(10) van Dyck, C., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21. www.nejm.org/doi/full/10.1056/NEJMoa2212948.MEDIA CONTACTSEisai Co., Ltd.Public Relations Department+81-(0)3-3817-5120Eisai Europe, Ltd.EMEA Communications Department+44 (0) 797-487-9419Emea-comms@eisai.netBiogen Inc. Jack Cox+ 1-781-464-3260public.affairs@biogen.comEisai Inc. (U.S.) Julie Edelman+1-862-213-5915Julie_Edelman@eisai.comINVESTOR CONTACTSEisai Co., Ltd.Investor Relations Department+81-(0) 3-3817-5122Biogen Inc. Stephen Amato+1-781-464-2442IR@biogen.comBiogen Safe HarborThis news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs; including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates; including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of the medicine; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Oct 31, 2024 - (JCN Newswire via SeaPRwire.com) -  Eisai Co. Ltd announced today that the latest findings on anti-MTBR (microtubule binding region) tau antibody E2814 were presented at the 17th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference, held in Madrid, Spain, and virtually. Eisai also announced initiation of a Phase II study (Study 202) on E2814 for sporadic early Alzheimer’s Disease (AD).Impact of the anti-MTBR tau antibody E2814 on tau pathology biomarkers in Dominantly Inherited Alzheimer’s Disease (DIAD)E2814 is an investigational anti-MTBR tau antibody designed to target the MTBR of tau. In AD patients, neurofibrillary tangles (NFT) are a pathological hallmark, and they are believed to spread through synaptically connected pathways in the brain, forming the tau propagation hypothesis. It is thought that tau propagation is drivenby the specific tau species containing MTBR, tau seeds that spread tau pathology to different brain regions important for cognition and function.Eisai conducted a Phase I/II clinical study (Study 103, NCT04971733; 7 participants) of the anti-MTBR tau antibody E2814 in patients with Dominantly Inherited Alzheimer’s Disease (DIAD) beginning in June 2021. This study aimed to evaluate the safety and tolerability of E2814 in DIAD patients, with a primary objective of assessing the target engagement of E2814 with MTBR-tau species in their cerebrospinal fluid (CSF). In addition, pharmacodynamicevaluation was performed using multiple biomarkers related to AD tau pathology. In the study, DIAD patients withclinical symptoms were administered E2814 for 12 to 24 months. Data from the Dominantly Inherited Alzheimer Network Observational Study (DIAN-obs), an observational cohort of DIAD, were used as references to evaluate biomarkers changes in E2814 treatment.Compared to the reference data from DIAN-obs, patients who received E2814 showed approximately 75% and 50% reductions of CSF MTBR-tau243 and p-tau217, respectively, reflecting tau pathophysiology. Additionally, braintau accumulation observed by tau PET was stabilized or trended toward decrease in DIAD subjects administered E2814. These results suggest that E2814 inhibited tau propagation and suppressed the accumulation of tau aggregates in brains of people living with DIAD. This will be further investigated in the ongoing Phase II/III Tau NexGen study (NCT05269394) with DIAD patients and the Phase II 202 study (NCT06602258) with sporadic early Alzheimer’s disease (AD) patients.Initiation of Phase II clinical study (Study 202)In September 2024, Eisai initiated a Phase II clinical study (Study 202) for individuals with early AD in the United States. The study is also scheduled to be conducted in Japan in the future. This study is a placebo- controlled,double-blind, parallel-group, dose exploration study, evaluating the safety, tolerability, and biomarker efficacy of E2814 in people living with early AD receiving lecanemab as a backbone anti-Aβ therapy.Eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of novel medicines based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of affected individuals and their families in diseases with high unmet needs, such as dementia including AD.This release discusses investigational uses of agents in development and is not intended to convey conclusionsabout efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.About E2814An investigational anti-microtubule binding region (MTBR) tau antibody, E2814 is being developed as a disease- modifying agent for tauopathies including sporadic Alzheimer’s disease (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. In addition, E2814 has been selected as an anti-tautherapy in a Phase II/III Tau NexGen study for the treatment of DIAD, conducted by DIAN-TU led by Washington University School of Medicine in St. Louis, is underway.Biomarkers related to AD tau pathologyAs fluid biomarkers related to AD tau pathology, tau containing the residue 243 (MTBR-tau243) and tau phosphorylated at theresidue 217 (p-tau217) in CSF have been reported.1 In addition, positron emission tomography (tau PET), which specifically detects tau aggregates, is used as an imaging biomarker. These biomarkers are included in the Revised criteria for diagnosis and staging of Alzheimer's disease published by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in June 2024.2(1) Horie K, et al. CSF MTBR-tau243 is a specific biomarker of tau tangle pathology in Alzheimer's disease. Nat Med. 2023. 29. 1954-1963(2) Jack Jr. CR, et al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024. 20. 5143-5169For further information: Media Inquiries:Eisai Co., Ltd.Public Relations Department TEL: +81 (0)3-3817-5120Eisai Inc. (U.S.) Libby Holman+1-201-753-1945Libby_Holman@Eisai.comEisai Europe, Ltd. (UK, Europe, Australia, New Zealand and Russia) EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.net Copyright 2024 JCN Newswire via SeaPRwire.com.