SAN DIEGO -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Conatus' drug candidate emricasan for the treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease. The FDA's Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions.
Conatus is developing emricasan, a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death (or apoptosis), for the treatment of patients with chronic liver disease and significant unmet medical need.
"The FDA's Orphan Drug Designation of emricasan for treatment of liver transplant patients with reestablished fibrosis reinforces the critical need for alternatives to the only currently available treatment, which is a second transplant," said Conatus Co-Founder, President and Chief Executive Officer, Stephen J. Mento, Ph.D. "This designation is a significant step forward for Conatus' clinical development program for emricasan."
About FDA Orphan Drug Designation
The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 people but are not expected to recover the costs of developing and marketing a treatment drug. Orphan Drug Designation confers special incentives to the drug developer, including tax credits on the clinical development costs, prescription drug user fee waivers and a possible seven-year period of marketing exclusivity in the U.S. for the drug if it subsequently receives the first FDA approval for the disease or condition for which it has such designation.
About Emricasan Clinical Development
Conatus is developing emricasan for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease. To date, emricasan has been studied in over 500 subjects in ten clinical trials. In a randomized Phase 2b clinical trial, emricasan demonstrated statistically significant, consistent, rapid and sustained reduction in elevated levels of two key biomarkers of inflammation and cell death that are implicated in the severity and progression of liver disease. Emricasan is currently in a Phase 2b clinical trial in patients with acute-on-chronic liver failure, as well as a Phase 2 clinical trial in patients with severe alcoholic hepatitis.
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 emricasan as 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.