Vertex Pharmaceuticals, a big biotech company, biopharma partners in a non-exclusive agreement with Bristol-Myers Squibb , a big pharma company, to conduct Phase 2 studies of once-daily all-oral treatment regimens containing Vertex’s nucleotide analogue hepatitis C virus polymerase inhibitor VX-135 and Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C.
As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in treatment-naïve people with genotype 1 HCV infection planned for the second quarter of 2013.
Under the terms of the agreement, Vertex will conduct two Phase 2 studies of VX-135 in combination with daclatasvir.
The first study will enroll approximately 20 non-cirrhotic, treatment-naïve people with chronic genotype 1 HCV infection and is expected to begin in the second quarter of 2013.
In the second half of 2013, Vertex 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.
Each of these studies is expected to evaluate safety, tolerability, pharmacokinetics and viral cure rates of multiple all-oral regimens of VX-135 and daclatasvir dosed once daily, pending regulatory discussions.
Vertex will also conduct co-formulation activities to evaluate the potential for development of a once-daily fixed-dose combination regimen.
Further clinical development activities beyond the Phase 2 studies are not covered as part of this agreement.
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