Vertex, BMS To Conduct Combo-HCV Studies

Vertex Pharmaceuticals has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct Phase II studies of once-daily oral treatments containing Vertex’s hepatitis C virus (HCV) polymerase inhibitor VX-135, and BMS’ NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. Vertex will conduct two Phase II studies of the combination, including an initial study in treatment-naïve people with genotype 1 HCV infection. Vertex plans to begin a subsequent study with genotype 1, 2 or 3 HCV, including those with cirrhosis, pending data from the initial study.
 
“With more than 170 million people infected worldwide, there is a critical need for new hepatitis C medicines that can offer people simpler and more tolerable treatment regimens that provide high cure rates,” said Robert Kauffman, M.D., Ph.D., senior vice president and chief medical officer at Vertex. “These studies with daclatasvir will provide the first opportunity to evaluate VX-135 as part of all-oral regimens in people with multiple hepatitis C genotypes and in people with cirrhosis.”