Conatus Pharmaceuticals Announces Publications Expanding on Previously Reported Results from Completed Phase 2 NAFLD-NASH, Portal Hypertension and Liver Cirrhosis Clinical Trials
Mitchell Schiffman, M.D., is the lead author on a new publication1 in Alimentary Pharmacology and Therapeutics detailing results from the double-blind, placebo-controlled Phase 2 NAFLD/NASH clinical trial. This trial enrolled 38 patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH). Patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for 28 days. Top-line results from the NAFLD/NASH clinical trial were released in March 2015and presented at The International Liver Congress™, the annual meeting of the European Association for the Study of the Liver(EASL), in April 20152.
Guadalupe Garcia-Tsao, M.D., is the lead author on a new publication3 in Hepatology detailing results from the exploratory, open-label Phase 2 Portal Hypertension clinical trial. This trial enrolled 23 patients with portal hypertension and compensated liver cirrhosis that was predominantly due to NASH or hepatitis C virus (HCV), including patients with active HCV infection and patients who had a sustained viral response to antiviral therapy. Patients received 25 mg of emricasan orally twice daily for 28 days. Top-line results from the Portal Hypertension clinical trial were released in September 2015and presented at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases(AASLD) in November 20154.
Catherine Frenette, M.D., is the lead author on a new publication5 in Clinical Gastroenterology and Hepatology detailing results from the Phase 2 Liver Cirrhosis trial. This trial enrolled 86 patients with liver cirrhosis, mild to moderate liver impairment and a Model for End-stage Liver Disease (MELD) score of 11 to 18 during the screening period. In the first phase of the trial, patients were randomized 1:1 to receive 25 mg of emricasan or placebo orally twice daily for 28 days. Top-line results from the first stage were released in January 2016and presented at the EASL annual meeting in April 2016. In the open-label second stage, patients who completed the first stage of the trial, either on treatment or placebo, received emricasan for up to an additional three months. Top-line results from the second stage were released in May 2016and presented at the AASLD annual meeting in November 20166.
“The results from this series of Phase 2 clinical trials led to the design of the three Phase 2b ENCORE clinical trials for NASH patients with liver fibrosis or cirrhosis,” said
In collaboration with
- 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;
- ENCORE-PH (for Portal Hypertension), for which top-line results were announced in
December 2018, has an ongoing six-month extension with 48-week liver function and clinical outcome results expected in mid-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 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 potential for the aggregate data from the ENCORE trials to support discussions regarding the further development of emricasan; the timeline for results from the ENCORE 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: the potential that further analysis of the data described herein or additional data may yield different results; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the U.S. Food and Drug Administration’s and other regulatory agencies’ approval processes and other regulatory requirements; and those risks described in the company’s prior press releases and in the periodic reports it files with the
1 Schiffman M et al. Randomised clinical trial: emricasan versus placebo significantly decreases ALT and caspase activation in subjects with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019;49:64-73.
2 Shiffman M et al. A placebo-controlled, multicenter, double-blind, randomised trial of emricasan (IDN-6556) in subjects with non-alcoholic fatty liver disease (NAFLD) and raised transaminases. Poster presented at EASL
3 Garcia-Tsao G et al. Emricasan (IDN-6556) Lowers Portal Pressure in Patients with Compensated Cirrhosis and Severe Portal Hypertension. Hepatol. 2018. DOI: 10.1002/hep.30199.
4 Garcia-Tsao G et al. Emricasan (IDN-6556) administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension. Late-breaking oral presentation at AASLD
5 Frenette, CT et al. Emricasan Improves Liver Function in Patients With Cirrhosis and High Model for End-stage Liver Disease Scores Compared With Placebo. Clin Gastroenterol Hepatol. 2018. DOI: 10.1016/j.cgh.2018.06.012.
6 Frenette C et al. Emricasan (IDN-6556) orally for three months in patients with cirrhosis and MELD scores 11-18 improves clinical parameters of cirrhosis in patients with baseline MELD score ≥15. Late breaker oral presentation at EASL
Source: Conatus Pharmaceuticals Inc.