Drug & Device Development

Polymerase inhibitor safely reduced HCV viral load in humans: phase I/II trial

Last Updated: 2004-05-18 16:15:17 -0400 (Reuters Health)

By Karla Gale

NEW ORLEANS (Reuters Health) - A novel HCV RNA polymerase inhibitor, NM283, has "impressive HCV antiviral activity and a favorable safety profile," according to results of a phase I/II dose escalation trial presented here at Digestive Disease Week.

NM283 suppresses HCV viremia in chimpanzees, Dr. Eliot Godofsky, at the University of Southern Florida in Tampa, told conference attendees. His group's trial included patients with chronic genotype 1 HCV with no evidence of cirrhosis. So far, 83 patients have completed the trial, in which 69 were treated with NM283 at doses of 50 to 800 mg/day, and 14 were treated with placebo, for 15 days with 14 days of follow-up.

All actively treated patients achieved > 70% reduction in viremia, he said, and among those with the highest cumulative dose, there was a 92% reduction in total vial burden.

There were no limiting toxicities or patterns of laboratory abnormalities, Dr. Godofsky said. Some patients experienced gastrointestinal symptoms during the first day or two of treatment, which resolved thereafter.

He noted that in chimpanzees, NM283 is highly synergistic with interferon-alpha, and his group now plans further trials to determine the maximum effective dose, alone and in concert with interferon treatment.

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.