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Re: DewDiligence post# 191201

Monday, 06/08/2015 12:16:02 PM

Monday, June 08, 2015 12:16:02 PM

Post# of 257458
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:

https://www.clinicaltrials.gov/ct2/show/NCT02217475

1-year data for primary endpoint is expected in Jun 2014, according to the above listing.

(I think Dew meant to say 2016, not 2014.)

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