Phase 2b trial initiated for treatment of NASH, liver fibrosis

A phase 2b clinical trial is underway to study the safety and efficacy of cenicriviroc to treat nonalcoholic steatohepatitis and liver fibrosis, according to a news release.

Cenicriviroc (Tobira Therapeutics) is an oral, potent immunomodulator that blocks chemokine receptors that can cause liver damage and lead to liver disease. Tobira has initiated the global trial, also known as CENTAUR, which includes 250 patients with NASH and liver fibrosis being dosed a 150-mg tablet of cenicriviroc once daily to determine any improvement in NASH or liver fibrosis compared with placebos.

“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,” Laurent Fischer, MD, chairman and CEO of Tobira, said in the release. “[Cenicriviroc] 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 [cenicriviroc] and advance our clinical investigation of a potential treatment option for patients with NASH.”

Approximately 580 patients have been treated with cenicriviroc in phase 1 and phase 2b clinical trials to date, including 115 patients infected with HIV-1, according to the release.

Between 3% and 5% of the US population is affected by NASH and liver fibrosis, according to the release.