“We were pleased to complete enrollment in the ENCORE-PH clinical trial on schedule,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “We thank the patients for participating in the trial, the clinical investigators and sites that met our stringent HVPG qualification criteria for conducting the trial, and the site monitoring teams for facilitating this timely achievement. 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.”
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.
Emricasan Clinical Development
In collaboration with Novartis, Conatus is conducting three randomized, double-blind, placebo-controlled Phase 2b clinical trials, the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan in patients with fibrosis or cirrhosis caused by NASH:
- 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.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development of novel medicines to treat liver disease. In collaboration with Novartis, Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. For additional information, please visit www.conatuspharma.com.
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 Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.