Tobira Therapeutics, Inc. has finished recruiting patients for its phase 2b CENTAUR study, which was designed to evaluate a therapy called cenicriviroc (CVC) in patients who suffer from non-alcoholic steatohepatitis (NASH) and liver fibrosis. The company, which is focused on developing and commercializing therapeutic options to treat liver and inflammatory conditions, announced enrollment completion in a press release.
Tobira is going to initiate CENTAUR to compare the effects of CVC with placebo in both NASH and liver fibrosis patients. The study is a global, double blind, placebo controlled, phase 2b clinical trial and the company anticipates it will be able to present one-year primary endpoint results by the middle of next year, while further details about CENTAUR and its demographics will be presented at an upcoming scientific conference.
“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,” stated Tobira’s CEO Laurent Fischer, MD. “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.”
As its primary endpoint, CENTAUR has a two-point improvement measure in accordance with the NAFLD Activity Score (NAS) accompanied by no progression of fibrosis. Further surrogate endpoints are going to be evaluated in the study, including resolution of NASH with no concurrent worsening of fibrosis stage and fibrosis improvement.
Tobira believes that CENTAUR may create the foundations for the approval of CVC by the regulatory authorities as a treatment for NASH patients with liver fibrosis. In addition, the company expects it can improve the lives of patients who suffer from NASH, a severe type of non-alcoholic fatty liver disease, which, in addition to liver fibrosis, type 2 diabetes and metabolic syndrome, is a risk factor for the development of more advanced liver complications like cirrhosis and liver cancer.