Novelos Therapeutics has filed an investigational new drug application (IND) with the FDA for NOV-205, its second clinical stage compound. The initial U.S.-based trial will evaluate NOV-205 as monotherapy for chronic hepatitis C patients who have failed pegylated interferon plus ribavirin therapy.
NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. Its 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 and significantly improved abnormal liver enzyme values. NOV-205 was well-tolerated in these studies, and its manufacturing is simple and low cost. The U.S.-based Phase Ib trial aims to expand the safety database for NOV-205 and assess its effects on the same key efficacy-related endpoints that showed improvement in the Russian studies.