Conatus Pharmaceuticals Dosed First Patient in Phase 2 Trial in Severe Alcoholic Hepatitis
SAN DIEGO - Conatus Pharmaceuticals (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced initiation of dosing in the Phase 2 clinical trial of emricasan in patients with severe alcoholic hepatitis. This study is being conducted by the Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT) Consortium consisting of the Mayo Clinic Rochester, Indiana University, and Virginia Commonwealth University in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
"We are very excited by this trial initiation of emricasan in patients with severe alcoholic hepatitis," said Steven J. Mento, Ph.D., President and Chief Executive Officer of Conatus. "We are developing emricasan as a first-in-class orally active treatment for chronic liver disease and acute exacerbations of chronic liver disease. Due to emricasan's mechanism of action and the presence of apoptosis and inflammation in many liver diseases, we believe there may be several patient populations that could potentially benefit from emricasan and have designed a comprehensive clinical program to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease."
The trial is a placebo-controlled, double-blind, multicenter study that is designed to assess whether emricasan improves the 28-day survival in patients with chronic liver disease caused by alcohol and contraindicated to receive corticosteroid therapy for their alcoholic hepatitis. The study is designed to also evaluate the role of apoptosis and sterile necrosis in alcoholic hepatitis, the safety and tolerability of emricasan, overall clinical outcomes, and pharmacokinetics in this patient population.
"We are looking forward to studying the potential beneficial effects of emricasan in patients afflicted by this severe disease,"said Vijay Shah, M.D., a hepatologist and principal investigator with the Mayo Clinic Rochester. "Alcohol-related liver disease is a major cause of morbidity and mortality in the U.S. and excessive alcohol consumption is the third leading preventable cause of death in the U.S."
Alcoholic liver disease encompasses a clinical/histological spectrum of disease including fatty liver, alcoholic hepatitis, and cirrhosis. Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. Severely affected patients show signs of retaining large amounts of fluid in the abdominal cavity (ascites), as well as kidney and liver failure. For additional information about the Phase 2 trial, please visit www.clinicaltrials.gov.
About Conatus Pharmaceuticals Inc.
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 in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the progression 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, including statements regarding the potential beneficial effects and development potential of emricasan, are forward-looking statements. 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' reliance on third parties to conduct its clinical trials, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; Conatus' ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; and those described in Conatus' prior press releases and 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.