- Results From Multicenter Phase 2 Portal Hypertension Clinical Trial in Patients With Liver Cirrhosis -
- Emricasan Significantly Lowered Portal Pressure in Patients With Severe Portal Hypertension -
SAN DIEGO, Oct. 20, 2015 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) announced today that a late-breaking abstract detailing results from the company's multicenter Phase 2 Portal Hypertension clinical trial in patients with liver cirrhosis has been accepted for oral presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco November 13-17, 2015.
The accepted abstract, "Emricasan (IDN-6556) administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension," was published today on the AASLD website at www.aasld.org/ and is scheduled for an oral presentation on November 16 at 4:15 p.m. PT by the abstract's lead author, Guadalupe Garcia‐Tsao, M.D., a principal investigator in the trial and Professor of Medicine (Digestive Diseases) at Yale University Medical School; Chief, Digestive Diseases, VA-CT Healthcare System; and Director, Clinical and Translational Core, Yale Liver Center.
The abstract's senior author, Jaime Bosch, M.D., Ph.D., the independent expert hepatic venous pressure gradient (HVPG) reader in the Portal Hypertension trial, Professor of Medicine, Liver Unit, Hospital Clínic-IDIBAPS, University of Barcelona; Director, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Ministerio de Economía y Competitividad; and Guest Professor at Bern University, Switzerland, said, "The study shows that emricasan given orally for 28 days significantly decreased the portal pressure gradient in patients with severe portal hypertension, probably by decreasing liver inflammation and decreasing the release of microparticles as a result of its anti-apoptotic effect. Reductions in HVPG of the magnitude observed are clearly associated with clinical benefit and reduce morbidity and mortality in this patient population. I look forward to further longer-term studies of emricasan to determine the potential role this therapy could have in the management of patients with cirrhosis and severe portal hypertension."
Additional abstracts previously accepted for posters at The Liver Meeting® addressing preclinical results with the company's pan-caspase inhibitors include, "Alcohol stimulates macrophage activation through caspase dependent, hepatocyte derived release of CD40L containing extracellular vesicles," (poster #1315), and "Emricasan, a pan caspase inhibitor, improves survival and portal hypertension in a murine model of long-term common bile-duct ligation," (poster #1522), both to be displayed on November 16 from 8:00 a.m. to 5:30 p.m. PT with authors available for discussion from 12:30 p.m. to 2:00 p.m. PT.
About Emricasan Clinical Development
To date, emricasan has been studied in over 600 subjects in fifteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. The company recently reported top-line results from its completed Portal Hypertension trial demonstrating emricasan's short-term effect on hepatic venous pressure gradient (HVPG), a potential surrogate clinical endpoint, in patients with liver cirrhosis and severe portal hypertension (HVPG ≥12 mmHg). The company's ongoing Phase 2 Liver Cirrhosis trial is evaluating emricasan's medium-term effect on liver function using two other potential surrogate clinical endpoints – Model for End-Stage Liver Disease (MELD) score and Child-Pugh-Turcotte (CPT) status. The company also is evaluating emricasan's longer-term effect on liver structure in its ongoing Phase 2b clinical trial in post-orthotopic liver transplant (POLT) recipients who have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection and have successfully achieved a SVR following HCV antiviral therapy (POLT-HCV-SVR). The company currently is developing a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. 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, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. 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: emricasan's potential role in the management of patients with cirrhosis and severe portal hypertension; the utility of HVPG as a surrogate endpoint for clinical trials of patients with liver cirrhosis; emricasan's potential medium-term effect on liver function; the utility of MELD and CPT as potential surrogate clinical endpoints; emricasan's potential longer-term effects on liver structure; the potential for emricasan to be a treatment for liver cirrhosis patients; and emricasan's potential to reduce caspase activity and interrupt disease progression across the spectrum of liver disease. 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: Conatus' ability to initiate and successfully complete current and future clinical trials; the risk that the past clinical trial results may not be predictive of future clinical results ; 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 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.