Idun Pharmaceuticals Inc announced positive data from its oral dose-ranging clinical trial of IDN-6556 for the treatment of liver impairment caused by Hepatitis C virus (HCV) infection. The data showed that when given orally, IDN-6556 normalized liver enzymes after just two weeks of twice-a-day dosing. Increased levels of aminotransferase enzymes are a well-accepted indicator of damage in the liver.
As was seen in an earlier trial with an intravenous form of IDN-6556, the drug was safe and well tolerated, and did not appear to exacerbate the HCV infection.
"The data is encouraging," Dr. Pockros said. "Together with the other investigators in the trial, I believe the drug may be useful in treating a number of liver diseases and will be studied further in patients with HCV. The study is ongoing and we hope to present additional data next year on its effects in patients with other liver diseases, such as fatty liver disease (NASH) and hepato-biliary disease."
IDN-6556 is a potent inhibitor of the key caspase enzymes that mediate apoptosis and is designed to protect liver cells (hepatocytes) from excessive programmed cell death. Increased rates of apoptosis have been implicated in many different liver diseases. Unfortunately, individuals suffering from these conditions have limited treatment alternatives, many of which are often poorly tolerated, expensive and do not cure most patients.
The ongoing clinical trial is a double-blind, placebo-controlled, dose-ranging study being conducted at six major hepatology hospitals in the United States. The presentation was based on data from 41 patients, over 70% of whom had failed to have an adequate response with currently approved treatments of HCV (interferon-alpha and ribavirin).
"The study shows that IDN-6556 can have beneficial effects in as little as two weeks in patients with HCV," said David Shapiro, Idun's Chief Medical Officer. "The data from this study in HCV-infected patients provides support for the evaluation of the drug in its oral form in other liver diseases as well. We are currently developing the plans for the next set of clinical studies in patients with HCV. We plan to study the effects of the drug in both patients that have failed to be successfully treated with the currently available drugs and, separately, with IDN-6556 given together with such therapy."
Idun also recently announced the initiation of another clinical trial of IDN-6556 in patients undergoing liver transplantation.