Vertex and Bristol-Myers to trial VX-135 and daclatasvir for hep C; B-MS names new R&D head

US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) has entered into a non-exclusive agreement with pharma major Bristol-Myers Squibb (NYSE: BMY) to conduct Phase II studies of once-daily all-oral treatment regimens containing Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and B-MS’NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. Financial terms were not disclosed.

As part of the agreement, Vertex plans to conduct two Phase II studies of the combination, including an initial study in treatment-naive people with genotype 1 HCV infection planned for the second quarter of 2013. Vertex plans to begin a subsequent study in treatment-naive people infected with genotype 1, 2 or 3 HCV, including those with cirrhosis, in the second half of 2013, 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, senior vice president and chief medical officer at Vertex, adding: “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.”