Novelos submits IND to US FDA on HCV drug

US biotechnology firm Novelos Therapeutics has filed an Investigational New Drug application with the Food and Drug Administration for NOV-205, its second clinical-stage compound to be evaluated as a monotherapy for chronic hepatitis C patients who have failed to respond to pegylated interferon plus ribavirin therapy.

The agent, which is designed to act as a hepatoprotective with immunomodulating and antiviral activity, has already been approved in the Russian Federation based on studies in hepatitis B and C in which it reduced or eliminated viral levels and significantly improved abnormal liver enzyme values. The USA-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, the firm noted.