Tobira Therapeutics (TBRA) Begins Phase 1 Combination Study of Cenicriviroc and Evogliptin

September 12, 2016 8:06 AM EDT

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Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, today announced the initiation of a Phase 1 study of cenicriviroc (CVC) in combination with evogliptin (EVO).

“NASH is a complex, multifactorial liver disease resulting from obesity and characterized by metabolic abnormalities, inflammation and fibrosis. We believe that patients will benefit the most from combination therapies that address multiple mechanisms of this disease. Thus, we are initiating a Phase 1 study of CVC and EVO, laying the foundation for rapidly advancing our combination program. This approach will enable us to provide comprehensive therapies for patients with liver fibrosis and NASH, who are at risk of progression to liver cirrhosis and currently have no approved treatment options,” said Laurent Fischer, M.D., chief executive officer at Tobira. “The data generated in the CENTAUR Phase 2b study demonstrated that CVC has potent anti-fibrotic activity and was well tolerated. We believe that the anti-fibrotic mechanism of CVC provides a solid backbone to which metabolically-targeted agents such as evogliptin can be added, giving the combination of CVC and EVO the potential to address multiple drivers of NASH.”

About the Phase 1 Combination Trial

The Phase 1 study is a single-center, open-label study in healthy adult subjects. The study’s primary objective is to evaluate the safety, tolerability and steady-state pharmacokinetic parameters of EVO when administered with and without CVC.

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