Vertex Pharmaceuticals has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct Phase II of "once-daily all-oral treatment regimens" containing VX-135 with the US major's daclatasvir for the treatment of hepatitis C.
Vertex plans to conduct two studies of the combination of VX-135, a nucleotide analogue HCV polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor. This will include a trial in treatment-naive people with genotype 1 HCV infection, the most common form of hepatitis, planned for the second quarter.
Vertex plans to begin a subsequent study in treatment-naive people infected with genotype 1, 2 or 3 of hepatitis C, including those with cirrhosis, in the second half of the year, pending data from the initial trial.
Vertex’s chief medical officer Robert Kauffman noted that with more than 170 million people infected worldwide, "there is a critical need for new HCV medicines that can offer people simpler and more tolerable treatment regimens that provide high cure rates".
B-MS is conducting late-stage trials of daclatasvir and the drug is also being studied in combination with Gilead Sciences' sofosbuvir and Johnson & Johnson's TMC435. Vertex' Incivek (telaprevir) and Merck & Co's Victrelis (boceprevir), both protease inhibitors, are the current standard of care for HCV and they requires ribavirin and an injection of interferon, which can cause serious side effects.