Vertex Pharmaceuticals has signed a non-exclusive agreement with Bristol-Myers Squibb Company to carry out Phase II all-oral studies of VX-135 in combination with daclatasvir for the treatment of hepatitis C.
The once-daily all-oral treatment regimens contain Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and Bristol-Myers‘ NS5A replication complex inhibitor daclatasvir.
Vertex senior vice president and chief medical officer Robert Kauffman said new hepatitis C medicines offering simpler and more tolerable treatment regimens and high cure rates are needed.
"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," Kauffman said.
According to the deal, Vertex will carry out two Phase II studies of the combination including an initial study in treatment-naïve people with genotype 1 HCV infection scheduled to begin in the second quarter of 2013.
Around 20 non-cirrhotic people with chronic genotype 1 HCV infection who are new to the treatment will be enrolled in the study.
Vertex plans to conduct the second study in 250 treatment-naïve people with genotypes 1, 2 and 3 hepatitis C, including people with cirrhosis, in the second half of 2013.
Both of these studies is designed to assess the safety, tolerability, pharmacokinetics and viral cure rates (SVR4 and SVR12) of once daily, multiple all-oral regimens of VX-135 and daclatasvir.
Co-formulation activities to assess the potential for development of a once-daily fixed-dose combination regimen will also be carried out.
Image: A Bristol-Myers Squibb R&D facility in Princeton, New Jersey, US. Photo: Courtesy of Coolcaesar.