The two will evaluate the utility of BMS’ daclatasvir (BMS-790 052) and Tibotec’s TMC435 in a series of trials.
Brian Daniels, Senior Vice President, Development, BMS, says the agreement is “a continuation of our leadership in forging partnerships to advance combination antiviral therapy”.
As part of the clinical trials, the companies will evaluate sustained viral response at 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens. These are: a once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; a once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and a once-daily treatment regimen of daclatasvir and TMC435 alone.
Daclatasvir was discovered by BMS through a genomics approach and is the first NS5A replication complex inhibitor to be investigated in clinical trials. It is currently in Phase III development.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels. “We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV.”
The studies are planned to commence in the first half of 2012.