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(MENAFN – JCN NewsWire) TOKYO, July 19, 2019 – (JCN Newswire) – Eisai Co., Ltd. announced that the presentation and discussions on treatment, including research data on Alzheimer's disease (AD), oral beta-amyloid cleavage enzyme (BACE) inhibitor (1) ), were presented in the "Discussion Topic" section of the AAIC "Discussion of the BACEi Trial Results: Challenges, Opportunities" at the International Conference of Alzheimer's & # 39; s Association (AAIC) held in Los Angeles, California, United States, July 14-18, 2019. In addition, Eisai organized a symposium on the Reasons and Opportunities for Drug Development for Pre-Clinical AD.
1. Targeted thematic session of AAIC (DiscussionofBACEiTrialFindings: Challenges and Opportunities)
During this session, each company presented information about their own BACE inhibitors. Eisai comprehensively presented the results of the following clinical and non-clinical studies, as well as the state of clinical studies concerning elenbecestat.
– The results of the non-clinical study did not show significant effects on the decrease in vertebral density and the impairment of mitochondrial function, in relation to deterioration of function cognitive, in patients with a significant decrease in beta-amyloid (Abeta) levels in the CSF, as an effect of elenbecestat.
– The safety data, including the evolution of cognitive function in 900 patients treated with treatment for 6 months or more, were periodically reviewed by the Data Safety Monitoring Board (DSMB). In its latest review, the DSMB recommended continuation of phase 3 MISSIONAD 1 and 2 elenbecestat studies without modification.
– In the phase II clinical study (Study 202), patients with mild cognitive impairment (MCI) due to AD or mild to moderate lymphadenopathy with confirmed tomography of the amyloid pathway and hypostreemission tomography (PET) were reduced to 18 years. month compared to the placebo group with amyloid PET.
– The total group of 50 mg Elenbecestat presented a less aggravated clinical badessment using the sum of clinical dementia clbadification boxes (CDR-SB) and the composite score of Alzheimer's disease (ADCOMS ) at 18 months compared to the placebo group. In study 202, elenbecestat suggested an acceptable tolerance.
– Elenbecestat was selected by the Alzheimer Clinical Trial Consortium (ACTC) as a treatment to be evaluated in a clinical clinical study targeting primary prevention (Study A3) and secondary prevention (Study A45 ) of the MA. Screening will begin in 2020.
2. Symposium sponsored by Eisai (Targeted therapy for preclinical Alzheimer's disease)
During this symposium, university pioneers presented on the issues and expectations of biological definition, molecular pathways and early treatment of AD. A lively discussion then took place.
The brain accumulation of beta-beta, which is the substance responsible for AD, begins one or two decades before the onset of memory symptoms in AD. Therefore, diagnosis and categorization on the basis of the pathology, and not the clinical symptoms, are necessary. In the latest AD clbadification ATN (amyloid, Tau, neurodegeneration / neuronal lesion), the concept that AD is a disease that changes with a sequence of events in the continuum of Alzheimer's disease has been Explain. With the evolution of biomarkers (blood, CSF, imaging), the current state, which determines the stages of AD, including preclinical AD, has been introduced. According to the progress of these diagnostic technologies, it has been indicated that a therapeutic intervention in preclinical AD is possible.
Reducing the production of toxic Abeta species through a targeted pathway-based therapy is a national research method that minimizes pathogenesis as far as possible. In addition, expectations regarding innovations in study design, the use of combination therapy, and the establishment of simplified blood diagnosis in the future were examined.
Eisai aims to prevent and cure dementia through a multidimensional and holistic approach based on more than 35 years of experience in drug discovery in the field of Alzheimer's disease and dementia. Eisai strives to create innovative medicines as soon as possible to further contribute to meeting the unmet medical needs of patients and their families, as well as to increase the benefits that result.
(1) Elenbecestat, is jointly developed by Eisai and Biogen Inc.
About Elenbecestat (generic name, development code: E2609)
Elenbecestat was discovered by Eisai. It is a new generation oral candidate for the treatment of Alzheimer's disease that inhibits BACE (beta-amyloid cleavage enzyme). By inhibiting BACE, a key enzyme in the production of Abeta peptides, elenbecestat reduces beta production and by reducing amyloid plaque formation in the brain, exerts disease-modifying effects that may slow the progression of AD. Currently, two global phase III (MISSION AD1 / 2) clinical studies of elenbecestat early in the disease, including mild cognitive impairment (MCI) due to disease or disease, are underway. In addition, the US Food and Drug Administration (FDA) has granted the Fast Track designation for the development of elenbecestat, a process that allows it to prioritize drugs that address critical illnesses and address needs. unmet medical conditions.
About a joint development agreement between Eisai and Biogen for Alzheimer's Disease
Eisai and Biogen collaborate on the joint development and commercialization of Alzheimer's disease treatments. Eisai is the co-development leader of Elenbecestat, an inhibitor of BACE, and BAN2401, an anti-amyloid antibody protofibril beta (Abeta), and companies are considering obtaining regulatory approvals. the market for both compounds in the world. If approved, companies will also participate in the joint promotion of products in major markets, such as the United States, the European Union and Japan. With regard to BAN2401 and elenbecestat, the two companies will also share the total costs, including research and development costs. Eisai will record all sales of elenbecestat and BAN2401 after marketing approval and product launch, and the profits will be shared equally between the companies.
About Eisai
Eisai Co., Ltd. is a leading pharmaceutical company based on research and development based in Japan. We define our corporate mission as "prioritizing patients and their families and increasing the benefits of health care", what we call our philosophy of human health care (hhc). With approximately 10,000 employees working in our global network of R & D facilities, manufacturing sites and marketing affiliates, we strive to realize our hhc philosophy by delivering innovative products in a variety of therapeutic areas with unmet medical needs. , including neurology and oncology.
In addition, we are investing in and participating in several partnership initiatives aimed at improving access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit www.eisai.com
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