Conatus完成NASH肝硬化抑制剂2期试验的入选

StephenW

Conatus completes enrollment in phase 2 trial for NASH cirrhosis inhibitor
May 1, 2018

Conatus Pharmaceuticals completed enrollment in its ENCORE-PH phase 2 clinical trial for emricasan, an orally-active pan-caspase inhibitor designed to treat nonalcoholic steatohepatitis-related cirrhosis, according to a press release.

“We look forward to the upcoming series of emricasan clinical trial readouts and the potential opportunity to advance this novel product candidate toward addressing the unmet medical needs of NASH fibrosis and cirrhosis patients,” David T. Hagerty, MD, executive vice president of clinical development at Conatus, said in the release.

Researchers designed the double-blind, placebo-controlled trial to evaluate the safety, dosing and efficacy of emricasan in NASH cirrhosis and the trial in collaboration with Novartis.

The investigators will conduct the trial at approximately 70 clinical sites across the U.S. and Europe with approximately 240 patients with NASH, either compensated or early decompensated liver cirrhosis, and severe portal hypertension.

The primary endpoint is the mean change in hepatic venous pressure gradient by 24 weeks, after which the researchers will follow the patients for 6 months to determine clinical outcomes.

Additionally, Conatus announced that it expects top-line results from the ENCORE-NF trial of emricasan for NASH-related fibrosis in the first half of 2019 and top-line results from the ENCORE-LF trial of emricasan for liver function in patients with decompensated NASH cirrhosis in the second half of 2019.

Reference: www.conatuspharma.com

StephenW

Conatus完成NASH肝硬化抑制剂2期试验的入选
2018年5月1日

根据新闻稿，Conatus制药公司完成了ENCORE-PH阶段2临床试验的入选，该试验用于emricasan，一种旨在治疗非酒精性脂肪性肝炎相关肝硬化的口服半胱天冬酶抑制剂。

“我们期待即将发布的emricasan临床试验系列产品以及推动这一新型产品候选药物朝着满足NASH纤维化和肝硬化患者未满足的医疗需求前进的潜在机会，”临床开发执行副总裁David T. Hagerty博士Conatus在发布会上表示。

研究人员设计了双盲，安慰剂对照试验，以评估Emricasan在NASH肝硬化中的安全性，给药和疗效，并与诺华合作进行试验。

研究人员将在美国和欧洲的大约70个临床地点进行试验，其中约有240名NASH患者，无论是代偿期还是失代偿期肝硬化，还是严重的门静脉高压症。

主要终点是24周时肝静脉压力梯度的平均变化，之后研究人员将追踪患者6个月以确定临床结果。

此外，Conatus宣布，预计2019年上半年Emricasan对NASH相关纤维化的ENCORE-NF试验的一线结果以及ENCORE-LF试验中Emricasan对失代偿期患者肝功能的一线结果2019年下半年NASH肝硬化。

参考：www.conatuspharma.com