Conatus Announces Completion of Enrollment in ENCORE-PH Phase 2b Clinical Trial of Emricasan in Patients with NASH Cirrhosis and Severe Portal Hypertension
“We were pleased to complete enrollment in the ENCORE-PH clinical trial on schedule,” said
The ENCORE-PH clinical trial is designed to evaluate safety, dosing and efficacy of emricasan in NASH cirrhosis as an integral part of the company’s initial registration strategy. The double-blind, placebo-controlled trial is being conducted at approximately 70 U.S. and EU clinical sites in approximately 240 patients with nonalcoholic steatohepatitis (NASH) who have compensated or early decompensated liver cirrhosis and severe portal hypertension confirmed by hepatic venous pressure gradient (HVPG) of ≥12 mmHg at baseline. Patients were randomized 1:1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 24 weeks. The primary endpoint is the mean change in HVPG from baseline to Week 24. Patients will continue to be followed for clinical outcomes in a six-month treatment extension period.
In collaboration with
- ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, with top-line results expected in the fourth quarter of 2018, as described above;
- ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and
- ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Conatus is a biotechnology company focused on the development of novel medicines to treat liver disease. In collaboration with
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: the advancement of emricasan to address unmet medical needs of NASH fibrosis and cirrhosis patients; the details of and the timelines to announce results from the ENCORE-PH, ENCORE-NF and ENCORE-LF clinical trials; and caspase inhibitors' potential to interrupt the progression of a variety of diseases. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those risks described in Conatus’ prior press releases and in the periodic reports it files with the
Source: Conatus Pharmaceuticals Inc.