February 4, 2012

Medivir/Tibotec HCV Drug Development

15-Nov-11

Phase II interferon free combination study with TMC435 and PSI-7977

This interferon free phase II combination study will commence shortly. It will evaluate TMC435 and PSI-7977 in combination with and without ribavirin for 12 and 24 weeks in genotype 1 patients who had a prior null response to Peg-IFN/RBV. The study design is now posted on www.clinicaltrials.gov.

TMC435HPC2002 - Phase II Trial of TMC435 in Combination With PSI-7977 in Prior G1 Null Responders to Peg-IFN/RBV, Hepatitis C-Infected Patients: 12 and 24 weeks, with & without rbv (4 arms), INF-free study

This study is currently recruiting participants.
Verified January 2012 by Tibotec Pharmaceuticals, Ireland

TMC435HPC2002 - Phase II Trial of TMC435 in Combination With PSI-7977 in Prior G1 Null Responders to Peg-IFN/RBV, Hepatitis C-Infected Patients

HCV polymerase collaboration

TMC649128 TMC649128, the first NS5B nucleoside polymerase inhibitor under the collaboration, entered into clinical development in Q1-2011. It was safe and well tolerated at all doses tested for up to 14 days. However the antiviral activity failed to meet the target product profile and therefore the clinical development has now been discontinued.

Nucleotide program

The focus of HCV polymerase collaboration is now on a liver targeted nucleotide polymerase inhibitor program. A clinical candidate has been selected and the project is now in preclinical development stage.

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