- Janssen Pharmaceuticals' (NYSE:JNJ) Janssen Research & Development, LLC initiates a Phase 2b clinical trial assessing the safety, pharmacokinetics and efficacy of different regimens of AL-335, odalasvir and simeprevir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1-6 infection, with and without cirrhosis.
- The global, open-label, four-arm study will randomize ~400 subjects to receive once-daily treatment for six or eight weeks. Participants in two of the four arms will be treated with the combination of AL-335, odalasvir and simeprevir while those in the other two arms will receive only AL-335 and odalasvir. The primary endpoint is the percentage cure rate as determined by SVR12. The trial should start next month and end in July 2017.
- AL-335 is a uridine-based nucleoside NS5B polymerase inhibitor being developed by Janssen unit Alios BioPharma. Odalasvir (formerly ACH-3102) is an NS5A inhibitor discovered by Achillion Pharmaceuticals (NASDAQ:ACHN). Simeprevir, a NS3/4A protease inhibitor, is currently marketed by Janssen as Olysio.