JNJ-4178 is a combination of three direct acting antivirals: simeprevir, a protease inhibitor developed by Janssen and Medivir, AL-335, a nucleotide-based HCV polymerase inhibitor, and odalasvir, an HCV NS5A inhibitor. Janssen is responsible for the global clinical development of JNJ-4178. It is currently in Phase II studies for hepatitis C.
Janssen (Johnson & Johnson)
Project status and Medivir participation
A phase IIb open-label study of the combination of simeprevir, odalasvir and AL-335, is ongoing in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus infection without cirrhosis. This global, multi-center study includes clinical trial sites in North America, Europe and Asia and forms part of Janssen’s global development program for JNJ-4178. The objectives of the phase IIb study are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir (25mg QD), and simeprevir (75mg QD) in treatment-naive and treatment-experienced non-cirrhotic subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection.
There is also an ongoing phase IIa study of the same triple combination treatment in patients with or without compensated cirrhosis.
Medivir will receive milestones and royalties, if the product is approved.