Tobira Therapeutics reports mixed results for NASH candidate cenicriviroc

USA-based Tobira Therapeutics (Nasdaq: TBRA) has released results from CENTAUR, its Phase IIb clinical trial evaluating the efficacy and safety of cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH) in 289 adults with liver fibrosis.

Although the study did not meet its primary endpoint of a two-point reduction in the NAFLD Activity Score, CENTAUR did demonstrate a clinically- and statistically-significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after only one year of treatment. Regulators have recently identified this endpoint for Phase III studies to support a marketing application. CENTAUR is the first randomized study to evaluate this as a pre-specified endpoint.

The company intends to meet with the US Food and Drug Administration as soon as possible in order to discuss the Phase III study design and plans to initiate a global pivotal study of CVC in 2017.

“Liver fibrosis is the most important feature of NASH and is independently associated with key outcomes including long-term overall mortality, liver transplantation, and liver-related events,” said Scott Friedman, chief, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai and CENTAUR study chairman. “The very favorable safety profile of CVC combined with the efficacy data underscore the potential of CVC to emerge as a treatment of fibrosis associated with NASH, at a time when there are no approved therapies yet for this growing epidemic,” noted Dr Friedman.