Novelos Therapeutics has announced that the FDA accepted the company's investigational new drug application (IND) for NOV-205, its second clinical stage compound. The initial U.S.-based Phase Ib trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype 1 patients who have failed pegylated interferon plus ribavirin therapy.
NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiinflammatory properties. Its recent regulatory approval in the Russian Federation was based on clinical studies in hepatitis B and C patients in which NOV-205 greatly reduced or eliminated hepatitis viral levels for at least 30 days post treatment and significantly improved or normalized serum biochemical markers of liver damage. NOV-205 was well-tolerated in these studies.