Conatus Announces Completion of Enrollment in ENCORE-LF Phase 2b Clinical Trial of Emricasan in Patients with Decompensated NASH Cirrhosis
“With screening in the ENCORE-LF clinical trial complete, we remain on track for clinical events as announced last quarter, with top-line results expected in mid-2019,” said
The ENCORE-LF clinical trial is designed to evaluate safety, dosing and efficacy of emricasan in patients with decompensated NASH cirrhosis as an integral part of the company’s initial registration strategy. The double-blind, placebo-controlled, trial is being conducted at approximately 90 U.S. clinical sites in approximately 210 patients with nonalcoholic steatohepatitis (NASH) who have stable decompensated liver cirrhosis. Patients were randomized 1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, or placebo twice daily for at least 48 weeks. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or Model for End-stage Liver Disease (MELD) score progression ≥4 points. Analysis of the primary endpoint will be triggered upon reaching a prespecified target number of events. An additional analysis is planned after all patients have completed at least 48 weeks of dosing.
In collaboration with
- ENCORE-LF (for Liver Function) with top-line results expected in mid-2019 as described above;
- ENCORE-NF (for NASH Fibrosis) with top-line results after 72 weeks of treatment for approximately 330 patients with NASH fibrosis expected in the first half of 2019; and
- ENCORE-PH (for Portal Hypertension) with top-line results after 24 weeks of treatment for 263 patients with NASH cirrhosis and severe portal hypertension announced in the fourth quarter of 2018, and results after 48 weeks of treatment for patients opting to continue expected in mid-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 details of and the timelines to announce results from the ENCORE-LF, ENCORE-NF and ENCORE-PH 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.