入组开始进行肝性脑病治疗的2a期试验

StephenW

Enrollment begins for phase 2a trial of hepatic encephalopathy therapy
August 14, 2019

Mallinckrodt announced the first patient has been enrolled in a phase 2a trial comparing MNK-6106, an L-ornithine phenylacetate, with Xifaxan for the treatment of liver cirrhosis and hepatic encephalopathy, according to a press release.

“Enrollment of the first patient in this clinical trial of investigational drug MNK-6106 marks another important milestone in the compound’s development program,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said. “The evaluation of the oral formulation will allow us to gain insights into the potential utility of this compound to manage patients whose acute episode of [hepatic encephalopathy] has resolved, and who may require longer-term treatment to reduce the likelihood of future episodes and potential complications.”

The phase 2a trial will comprise approximately 48 patients with cirrhosis, two or more documented episodes of hepatic encephalopathy within the previous 12 months, and hyperammonemia at the time of screening. Investigators will randomly assign patients to receive MNK-6106 at one of three doses or Xifaxan (rifaximin, Salix Pharmaceuticals).

Mallinckrodt expects study completion by the first quarter of 2020. Additionally, the company expects to begin recruiting for a phase 3 clinical trial of MNK-6105, another L-ornithine phenylacetate, in patients hospitalized for acute hepatic encephalopathy.

Reference: www.mallinckrodt.com

StephenW

入组开始进行肝性脑病治疗的2a期试验
2019年8月14日

Mallinckrodt宣布，第一名患者参加了一项2a期试验，根据一份新闻稿，比较MNK-6106（L-鸟氨酸苯乙酸盐）和Xifaxan治疗肝硬化和肝性脑病。

“在这项研究药物MNK-6106的临床试验中，第一名患者的入组标志着该大院开发计划的另一个重要里程碑，”Mallinckrodt执行副总裁兼首席科学官Steven Romano博士表示。 “对口服制剂的评估将使我们能够深入了解该化合物用于治疗[肝性脑病]急性发作已解决的患者的潜在效用，以及可能需要长期治疗以减少未来发作的可能性和潜在的并发症。“

2a期试验将包括大约48名患有肝硬化的患者，在过去12个月内记录的两次或更多次肝性脑病发作，以及筛查时的高氨血症。研究人员将随机分配患者接受三种剂量中的一种或Xifaxan（利福昔明，Salix Pharmaceuticals）接受MNK-6106。

Mallinckrodt预计研究将在2020年第一季度完成。此外，该公司预计将开始招募针对急性肝性脑病住院患者的另一种L-鸟氨酸苯乙酸MNK-6105的3期临床试验。

参考：www.mallinckrodt.com