ICN Pharmaceuticals plans to soon begin Phase III clinical trials of its experimental hepatitis C treatment Viramidine®, a drug that is being viewed as a potential alternative to ribavirin.
The Costa Mesa, CA-based company is developing Viramidine as an oral drug that the liver enzyme adenosine deaminase converts into ribavirin. The upcoming trial will test Viramidine's effect on the hepatitis C virus in combination with pegylated interferon.
ICN decided to proceed with Phase III trials after recently presenting positive data from a 12-week Phase II trial to the U.S. Food and Drug Administration. The Phase II trial involved 180 patients and showed that Viramidine, in combination with a pegylated interferon, produced a clinically significant reduction in viral load.
In addition, the trial showed that Viramidine, when compared with ribavirin, produced about half the drop in hemoglobin levels beginning in the fourth week of treatment.
The Phase III trial will consist of two studies in 80 sites with approximately 1,000 patients in each study.
Other sources: ICN Pharmaceuticals