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Tobira starts dosing in Phase IIb trial of cenicriviroc in non-alcoholic steatohepatitis

Tobira Therapeutics has started dosing in its Phase IIb clinical trial CENTAUR of cenicriviroc (CVC), an oral, once-daily, potent immunomodulator, in patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis.

CVC blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure.

The randomized, double-blind Phase IIb CENTAUR trial is designed to evaluate a single 150mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis.

The initiation of the CENTAUR trial follows the completion of a Phase I safety trial in patients with liver cirrhosis.

So far, around 580 patients have been dosed with CVC in Phase I and Phase IIb clinical trials, including 115 HIV-1 infected patients on treatment for up to 48 weeks.

Tobira Therapeutics chairman and CEO Dr Laurent: "Initiating a Phase IIb clinical study with CVC in NASH, a potentially life threatening liver disease for which there are no approved therapies, is an important milestone for Tobira.

"CVC has previously demonstrated dual inhibition of CCR2 and CCR5, key regulators of signaling pathways in NASH that lead to liver damage and disease.

"This study will help further determine if these drivers are responsive to CVC and advance our clinical investigation of a potential treatment option for patients with NASH."

About 250 patients will be enrolled in the trial at centers across North America, Europe and Australia.