- Interim results from Janssen's (NYSE:JNJ) Phase 2a clinical assessing a triple combination therapy for the treatment of HCV showed a 100% cure rate in as little as six weeks. The data will be presented at the European Association for the Study of the Liver Special Conference in Paris, September 23 - 24.
- The aim of the ongoing study is to confirm the required dose and treatment duration for an all-oral combination regimen of odalasvir and AL-335 with or without simeprevir for six or eight weeks in treatment-naive HCV genotype 1 patients.
- The 20 subjects in cohort 1 received a daily dose of the combination of odalasvir (50 mg), AL-335 (400 mg) and simeprevir (100 mg) for eight weeks. All achieved clinical cure 24 weeks after completed therapy (SVR24).
- The 20 patients in cohort 2 received 800 mg of AL-335 every day and 50 mg of odalasvir every other day for eight weeks. The cure rate at 12 weeks post treatment (SVR12) was 90%.
- The 20 subjects in cohort 3 received 800 mg of AL-335 and 75 mg of simeprevir every day and 50 mg of odalasvir every other day for eight weeks. All achieved clinical cure four weeks after the end of therapy (SVR4).
- The 20 subjects in cohort 4 received the same regimen as cohort 3 but for only six weeks. HCV RNA was negative in 90% (n=18/20) and the other two were below the limit of quantitation at the end of treatment.
- The triple combination (odalasvir 25 mg, AL-335 800 mg, simeprevir 75 mg) once daily will now be assessed in a Phase 2b study in 400 patients with chronic HCV 1-6 infection. According to ClinicalTrials.gov, the estimated study completion date is July 2017. The Phase 2a will be expanded to include HCV-2 and -3 and those with or without compensated cirrhosis.
- 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 (OTC:ACHN). Simeprevir, a NS3/4A protease inhibitor, is currently marketed by Janssen as Olysio.