Tibotec Enters Agreement With BMS for Phase II Combination Study
Bristol-Myers Squibb Company recently announced it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals’ investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).
Under the agreement, the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels, Senior Vice President, Development. “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. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy.”
Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir is the first NS5A replication complex inhibitor to be investigated in clinical trials and is currently in Phase III development. Daclatasvir is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
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