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MYR Pharma完成Myrcludex B在慢性肝炎D的临床试验 [复制链接]

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发表于 2018-3-13 11:06 |只看该作者 |倒序浏览 |打印
MYR Pharma Completes Clinical Trial of Myrcludex B in Chronic Hepatitis Delta

Myrcludex B is tested in the treatment of HDV - the most severe form of viral hepatitis without current satisfactory treatment options

120 subjects were enrolled into MYR 202, making it the world's largest HDV clinical study

News provided by
MYR Pharma

11:04 ET

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BURGWEDEL, Germany, March 12, 2018 /PRNewswire/ -- MYR Pharma GmbH today announced the completion of its MYR 202 clinical trial, a Phase 2b study investigating Myrcludex B in chronic hepatitis Delta (HDV), the most severe form of viral hepatitis that currently has no satisfactory treatment options. A total of 120 subjects were enrolled into MYR 202 in 20 centers in Russia and Germany, which makes it the world's largest HDV clinical study. The results of the study will be presented at the General Session of the upcoming International Liver Congress, an annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France on April 12, 2018.

"The positive results of the active therapy phase of this study were already presented at the AASLD meeting in Washington, DC in October 2017," said Alexander Alexandrov, MD, Chief Medical Officer of MYR Pharma. "The follow-up phase of this study is now completed. This is a very important milestone in the development of Myrcludex B under the PRIME scheme in Europe," he added.

"We appreciate that the EASL annual meeting organizers recognize the significance of the HDV medical problem and the importance of the results of this so far largest study with a novel compound in hepatitis Delta", said Heiner Wedemeyer, MD, Professor at Essen University Hospital and Chairman of MYR Pharma's Clinical Advisory Board.

About Myrcludex  B

Myrcludex B is a first-in-class entry inhibitor for the treatment of chronic hepatitis B (HBV) and its co-infection hepatitis Delta. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. The drug has received Orphan Designation for treatment of HDV infection from the EMA and FDA, and PRIME scheme eligibility from the EMA.

To find out more about Myrcludex B, visit http://myr-pharma.com/science/about-myrcludex-b.

About MYR Pharma

MYR Pharma GmbH is a German clinical stage biotechnology company focused on the development of drugs for the treatment of chronic hepatitis B and Delta virus infections. For more information, please visit http://myr-pharma.com.

Contact:  Alexey Eliseev, 1-617-953-0767

SOURCE MYR Pharma

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发表于 2018-3-13 11:06 |只看该作者
MYR Pharma完成Myrcludex B在慢性肝炎三角洲的临床试验

Myrcludex B用于治疗HDV--最严重的病毒性肝炎,目前没有令人满意的治疗方案

120名受试者被纳入MYR 202,成为世界上最大的HDV临床研究

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东部时间11:04

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- 2018年3月12日,德国BURGWEDEL / PRNewswire / - MYR Pharma GmbH今天宣布完成MYR 202临床试验,一项2b期研究,调查Myrcludex B在慢性肝炎三角洲(HDV)病毒性肝炎中的最严重形式,目前没有令人满意的治疗选择。在俄罗斯和德国的20个中心共有120名受试者参加了MYR 202,这使它成为世界上最大的HDV临床研究。研究结果将于2018年4月12日在法国巴黎召开的欧洲肝脏研究协会(EASL)年会上公布于即将举行的国际肝脏大会的大会上。

“这项研究的积极治疗阶段的积极结果已经在2017年10月在华盛顿举行的AASLD会议上提出,”MYR Pharma首席医疗官医学博士Alexander Alexandrov说。 “这项研究的后续阶段已经完成,这是欧洲PRIME计划下Myrcludex B发展过程中一个非常重要的里程碑,”他补充道。

“我们非常欣赏EASL年会的组织者认识到HDV医学问题的重要性以及迄今为止这项迄今为止最大规模的研究结果对于肝炎三角洲中新型化合物的研究结果的重要性,”埃森大学医院教授Heiner Wedemeyer医师和MYR Pharma临床顾问委员会主席。

关于Myrcludex B

Myrcludex B是治疗慢性乙型肝炎(HBV)及其合并感染性肝炎三角洲的一流入门抑制剂。该药抑制肝细胞表面最近鉴定的HBV受体,并防止健康细胞的感染和病毒在肝内的扩散。该药物已获得孤儿指定用于治疗来自EMA和FDA的HDV感染,以及来自EMA的PRIME计划资格。

要了解有关Myrcludex B的更多信息,请访问http://myr-pharma.com/science/about-myrcludex-b

关于MYR Pharma

MYR Pharma GmbH是一家德国临床阶段生物技术公司,专注于开发治疗慢性乙型肝炎和三角洲病毒感染的药物。欲了解更多信息,请访问http://myr-pharma.com

联系人:Alexey Eliseev,1-617-953-0767

消息来源MYR Pharma

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发表于 2018-3-13 23:36 |只看该作者
回复 StephenW 的帖子

结果总结一下??没有什么突破吗??

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发表于 2018-3-14 16:51 |只看该作者
回复 hp121 的帖子

结果将在4月份的EASL大会上公布, 需要等等.
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