TBRA completes recruitment in Phase 2b NASH study. Stock up 25%
8:06 am Tobira Therapeutics completes patient recruitment for CENTAUR Phase 2b study of Cenicriviroc in NASH with Liver Fibrosis; Results of the one-year primary endpoint are anticipated to be announced in mid-2016 (TBRA) : Co announced that it has completed recruitment for the Phase 2b CENTAUR study. CENTAUR is a global, double blind, placebo controlled, Phase 2b clinical trial evaluating the treatment effects of cenicriviroc (CVC) versus placebo in patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis at high risk of progressive disease. Results of the one-year primary endpoint are anticipated to be announced in mid-2016. Tobira plans to submit further detail regarding study demographics for presentation at an upcoming scientific conference. The primary endpoint of the CENTAUR study is a two-point improvement in NAS (NAFLD Activity Score) without progression of fibrosis.
TBRA thinks phase-2 CENTAUR study could lead to an application for FDA accelerated approval in NASH based on 1-year data: