Bristol-Myers Squibb has signed a clinical collaboration agreement with Medivir development partner Tibotec Pharmaceuticals for Phase II combination study in patients with chronic hepatitis C virus.
The companies will assess the use of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, along with Tibotec Pharmaceuticals' NS3 protease inhibitor TMC435 in the treatment of chronic hepatitis C.
TMC435, a once-daily NS3/4A protease inhibitor being jointly developed by Tibotec Pharmaceuticals and Medivir, will be evaluated in conjugation with Bristol-Myers Squibb´s daclatasvir for the treatment of genotype-1 chronic hepatitis C.
Under the deal, the companies will investigate the ability to attain sustained viral response 12 and 24 weeks after treatment in patients with hepatitis C virus genotype 1 in a study with three treatment regimens.
There will be three oral, once-daily treatment regimens: daclatasvir and TMC435 with pegylated-interferon alpha and ribavirin; daclatasvir and TMC435 with just ribavirin; and daclatasvir and TMC435 alone.
The Phase II combination study is scheduled to commence in the first half of 2012.
Medivir R&D executive vice-president Charlotte Edenius said their collaboration work with Bristol-Myers Squibb to demonstrate the ability of its protease inhibitor, TMC435, with an NS5A replication complex inhibitor will enable the advancement of novel treatment options for people chronically infected with hepatitis C.
Bristol-Myers Squibb Development senior vice president Brian Daniels said the company is dedicated to developing innovative treatment options for patients with serious diseases like hepatitis C.
"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 hepatitis C. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy," Daniels said.
TMC435 is being developed in three global Phase III studies. QUEST-1 and QUEST-2 involve treatment-naïve patients, while PROMISE involves patients who have relapsed after prior interferon-based treatment.
Caption: Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with hepatitis C virus.