美國Seres Therapeutics, Inc.公司研發(fā)的微生態(tài)制劑SER109 是一種口服微生物藥物,用于治療成人復發(fā)性艱難梭菌感染(CDI)。2015年6月12日,FDA已認定SER-109為突破性治療藥品。2015年8月21日,FDA又授予SER-109孤兒藥資格。目前該產(chǎn)品已完成臨床 1 期,現處于臨床 2 期研究中。
About SER-109
SER-109 is the lead Ecobiotic? microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium Difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics? platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to a healthier state. CDI is a rapidly growing problem associated with antibiotic use. Approximately 85,000 to 110,000 CDI patients in the U.S. have more than one recurrence each year.
More information : http://ir.serestherapeutics.com/phoenix.zhtml?c=254006&p=irol-newsArticle&ID=2081167
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