Tobira completes recruitment for CENTAUR trial for NASH

Tobira Therapeutics, Inc. has completed recruitment for its phase 2b clinical trial known as CENTAUR, which will investigate the safety and efficacy of cenicriviroc for nonalcoholic steatohepatitis and liver fibrosis, according to a press release from the manufacturer.

Cenicriviroc (Tobira Therapeutics) is an oral, potent immunomodulator that blocks chemokine receptors that can cause liver damage and lead to liver disease, according to the manufacturer. Tobira first initiated the global trial in October 2014 and will include 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.

“To our knowledge, CENTAUR is the first NASH study to prospectively focus on high-risk patients who are in most urgent need of therapy and is designed to assess multiple aspects of the disease over an extended, two-year period,” Laurent Fischer, MD, chief executive officer of Tobira, said in the release. “The robust CENTAUR study also helps advance the understanding of NASH and potential surrogate endpoints by evaluating non-invasive measurements, biomarkers, and other exploratory endpoints.”

The primary endpoint of the CENTAUR study is a two-point improvement in NAFLD Activity Score without progression of fibrosis, according to the release. Secondary endpoints of the clinical trial include resolution of NASH with no concurrent worsening of fibrosis stage and measures of fibrosis improvement. Results are expected to be announced in 2016, according to Tobira.

The FDA granted fast track designation to Tobira Therapeutics for cenicriviroc in January. – by Melinda Stevens

Disclosure: Fischer is employed by Tobira.