Biotechnology firm Conatus Pharmaceuticals (CNAT) has started dosing in the Phase II clinical trial of emricasan, an orally active caspase protease inhibitor, in patients with severe alcoholic hepatitis.
The Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT) consortium comprising Mayo Clinic Rochester, Indiana University, and Virginia Commonwealth University in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is carrying out the trial.
The placebo-controlled, multicentre and double-blind trial is intended to assess if emricasan can improve the 28-day survival in patients with chronic liver disease caused by alcohol and contraindicated to receive corticosteroid therapy for their alcoholic hepatitis.
Conatus president and CEO Steven Mento said the company is developing emricasan as an 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 programme to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease," Mento said.
The trial will also assess the role of apoptosis and sterile necrosis in alcoholic hepatitis, the safety and tolerability of emricasan as well as the overall clinical outcomes and pharmacokinetics in the patients.
Mayo Clinic Rochester hepatologist and principal investigator Vijay Shah said: "Alcohol-related liver disease is a major cause of morbidity and mortality in the US and excessive alcohol consumption is the third leading preventable cause of death in the US."
The company believes emricasan has the potential to interrupt the progression of liver disease by reducing the activity of enzymes that mediate inflammation and cell death.
Alcoholic liver disease includes a clinical/histological spectrum of disease such as fatty liver, alcoholic hepatitis and cirrhosis.
Image: High magnification micrograph of a Mallory body, as seen in steatohepatitis. Photo: courtesy of Nephron.