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EISAI PRESENTS LATEST CLINICAL FINDINGS SUGGESTING INHIBITION OF TAU PROPAGATION BY ANTI-MTBR TAU ANTIBODY E2814 AT THE 17TH CLINICAL TRIALS ON ALZHEIMER'S DISEASE CONFERENCE (CTAD) | ||
By: PR Newswire Association LLC. - 31 Oct 2024 | Back to overview list |
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-Eisai Initiates Phase II Clinical Study on Sporadic Early Alzheimer's Disease- TOKYO, Oct. 30, 2024 /PRNewswire/ -- Eisai Co. Ltd (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") 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) 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, pharmacodynamic evaluation was performed using multiple biomarkers related to AD tau pathology. In the study, DIAD patients with clinical 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, brain tau 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) 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 conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. [Notes to editors]
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View original content to download multimedia:https://www.prnewswire.com/news-releases/eisai-presents-latest-clinical-findings-suggesting-inhibition-of-tau-propagation-by-anti-mtbr-tau-antibody-e2814-at-the-17th-clinical-trials-on-alzheimers-disease-conference-ctad-302292174.html SOURCE Eisai Inc. |
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