US-based biopharmaceutical firm Tobira Therapeutics has started the dosing process for CENTAUR, the Phase IIb clinical trial 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 randomised, double-blind Phase IIb CENTAUR trial is designed to evaluate a single 150mg tablet of CVC given once daily versus a placebo in patients with NASH and liver fibrosis.
The start of the CENTAUR trial follows the completion of a Phase I safety trial in patients with liver cirrhosis.
Currently, more than 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 CEO Dr Laurent Fischer said: "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.
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"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."
An average of 250 patients will be enrolled in the trial at centres across North America, Europe and Australia. The trial will evaluate the improvement of NASH and liver fibrosis at both one and two years and compare it to a patient taking a placebo.
The company has showed significant anti-fibrotic activity of CVC in preclinical models of liver and kidney disease.
Icahn School of Medicine chief of the division of liver diseases Scott Friedman said: "The rising prevalence of obesity in the United States and Western Europe is associated with an alarming increase in NASH leading to advanced liver fibrosis and cirrhosis.
"Cenicriviroc, with its favorable safety profile and scientific evidence of an anti-inflammatory and anti-fibrotic effect is the first drug in its class in development to target the damage and scarring resulting from fat and inflammation in the liver."