Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing cenicriviroc (CVC) in liver disease and HIV, has dosed the first patient in its CENTAUR study of patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis, a disease affecting approximately 3-5 per cent of the US population.
The initiation of the CENTAUR study follows the completion of a phase 1 safety study in subjects with liver cirrhosis. To date, approximately 580 subjects have been dosed with CVC in phase 1 and phase 2b clinical studies, including 115 HIV-1 infected subjects on treatment for up to 48 weeks.
"Initiating a phase 2b 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," commented Dr. Laurent Fischer, chairman and CEO of Tobira Therapeutics. "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."
CVC is an oral, once-daily, potent immunomodulator that 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. Tobira has demonstrated significant anti-fibrotic activity of CVC in preclinical models of liver and kidney disease.
"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," stated Scott Friedman, M.D., chief of the Division of Liver Diseases and Dean of Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, and a world renowned NASH expert. Dr. Friedman is the CENTAUR study chairman.
The CENTAUR study is a randomized, double-blind phase 2b study of a single 150mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis. CENTAUR is a global study with planned treatment centers across North America, Europe and Australia. The study will enroll approximately 250 patients and will evaluate the improvement of NASH and liver fibrosis at both one and two years as compared to placebo. For additional information on the CENTAUR study, please visit clinicaltrials.gov using the identifier NCT02217475.