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Janssen readies mid-stage study of short
duration HCV combo regimen for genotypes 1-6
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May 11 2016
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 (NS5A ACH-3102)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.
J&J HCV Update: AL335+ACH3102+Simeprevir Phase 2 Study - (05/06/16)
at EASL:
J&J
EASL:PAN-GENOTYPIC EVALUATION OF AL-335, A CLINICAL STAGE URIDINE ANALOG INHIBITOR OF HEPATITIS C VIRUS POLYMERASE - (04/18/16)
EASL:AL-335, A ONCE-DAILY PANGENOTYPIC NUCLEOTIDE HCV POLYMERASE INHIBITOR, DEMONSTRATES POTENT ANTIVIRAL ACTIVITY OVER 7 DAYS IN TREATMENT-NAïVE GENOTYPE 1-4 PATIENTS - (04/18/16)
J&J will study NS5A inhibitor ACH-3102 + simeprevir + AL-335 in a 3 drug regimen.
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