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news.Bristol-Myers Squibb Company has entered into a clinical collaboration agreement with Sweden-based Medivir's development partner, Tibotec Pharmaceuticals for Phase II combination study in patients with chronic hepatitis C virus (HCV).
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The collaboration is intended to evaluate the utility of Daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, along with Tibotec Pharmaceuticals’ NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C.
TMC435 is a potent and selective once-daily investigational NS3/4A protease inhibitor that is being jointly developed by Tibotec Pharmaceuticals and Medivir to treat chronic hepatitis C virus infections in genotype 1 patients.
The Phase II combination study is scheduled to commence in the first half of 2012.
Medivir Research & Development executive vice president Charlotte Edenius said along with Bristol-Myers Squibb, Medivir will demonstrate the ability of its protease inhibitor, TMC435, with an NS5A replication complex inhibitor to advance novel treatment options for people chronically infected with HCV.
”We believe that an all oral, treatment regimen for HCV would represent a major step towards improved HCV treatments," Edenius added.
The US Food and Drug Administration has granted fast track designation for TMC435 to treat chronic hepatitis C (CHC) genotype-1 infection.