Baijian and Eisai Alzheimer's drug clinical phase 2 failed to meet the standard
December 22, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On December 21, Japan's Eisai and the US Baijian Pharmaceutical announced that the Independent Data Monitoring Committee has determined that the anti-β-amyloid fibril antibody BAN2401 failed to meet the criteria for successful trials, ie, the clinical participation of 856 patients. The primary endpoint based on the 12-month Bayesian analysis was not reached in the trial (Study 201).
Following a predetermined study protocol, the double-blind study will continue and a comprehensive final analysis will be conducted at 18 months to seek clinically meaningful results. The final analysis results are expected to be available in the second half of 2018.
Study 201 (Clinical Accession No. NCT01767311) is a placebo-controlled study in patients with cerebral amyloid marker-positive prodromal or mild Alzheimer's disease (collectively referred to as early Alzheimer's disease). Randomized double-blind, parallel group study. The study design included 16 interim analyses to assess the likelihood of drug discontinuation or termination due to safety. None of these conditions were met and the study will continue the full analysis at 18 months. The efficacy of the BAN2401 five-dose group was evaluated at 12 months, based on an endpoint developed by Eisai (Alzheimer's Disease Comprehensive Score - ADCOMS). Based on a 12-month Bayesian analysis, the trial was successfully determined to achieve a clinically significant difference of 80% or higher (clinically significant difference: ADCOMS decline rate of 25% or greater compared to placebo).
In the final analysis of 18 months, a comprehensive evaluation of the clinical evaluation indicators ADCOMS and clinical dementia assessment kit (CDR-SB) from baseline will be included, in addition, changes in biomarkers will be assessed, for example, starch Changes in brain amyloid levels measured by PET and total hippocampal volume measured by vMRI.
Dr. Lynn Kramer, Chief Clinical Officer and Chief Medical Officer of Eisai Neurology, said: "By using Bayesian statistics in this uniquely designed trial, we hope it will prove clinical success faster than traditional research designs. We will now wait for the final study analysis after 18 months of treatment, which means that the amount of time is suitable for assessing the efficacy of Alzheimer's disease treatment."
BAN2401 is a humanized monoclonal antibody for the treatment of Alzheimer's disease. It can selectively bind to toxic Aβ aggregates. It is the result of a strategic research alliance reached by Eisai and BioArctic AB in Sweden in December 2007. Since March 2014, Eisai and Baijian have jointly developed BAN2401. In the field of treatment and product development and commercialization of Alzheimer's disease, there is extensive cooperation and connection between Eisai and Baijian. (Sina Pharmaceutical Compilation / David)
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