Vertex, Bristol-Myers to conduct phase 2 studies of VX-135 in combination with daclatasvir

The first study, which is expected to begin in the second quarter of 2013, will enroll approximately 20 non-cirrhotic, treatment-naïve people with chronic genotype 1 HCV infection.

Vertex also plans to conduct a subsequent study in approximately 250 treatment-naïve people with chronic genotype 1, 2 or 3 HCV infection, including those with cirrhosis, in the second half of 2013.

Each study is expected to evaluate safety, tolerability, pharmacokinetics and viral cure rates (SVR4 and SVR12) of multiple all-oral regimens of VX-135 and daclatasvir dosed once daily, pending regulatory discussions.

Vertex senior vice president and chief medical officer Robert Kauffman said that there is a critical need for new hepatitis C medicines, which are high tolerable treatment regimens that provide high cure rates.

"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 added.

Vertex will also conduct co-formulation activities to assess the potential for development of a once-daily fixed-dose combination regimen.

VX-135 is a uridine nucleotide analogue pro-drug designed to inhibit the replication of the hepatitis C virus while Daclatasvir is an NS5A replication complex inhibitor that is being studied as a key component of potential DAA-based hepatitis C treatment regimens.