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Trials & Filings

Conatus Liver Treatment Gets Orphan Status

First-in-class oral treatment can reduce inflammation, cell death

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Conatus Pharmaceuticals has received Orphan Drug Designation from the FDA for the 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.

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), for the treatment of patients with chronic liver disease and significant unmet medical need.

Emricasan is currently in a Phase IIb clinical trial in patients with acute-on-chronic liver failure, as well as a Phase II clinical trial in patients with severe alcoholic hepatitis.

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