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Actionable news in TBRA: Tobira Therapeutics Inc,

Tobira Therapeutics Announces Clinically and Statistically Significant Improvement in Liver Fibrosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 results from CENTAUR, its Phase 2b clinical trial evaluating the efficacy and safety of cenicriviroc (CVC) for the treatment of 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 3 studies to support a marketing application. CENTAUR is the first randomized study to evaluate this as a pre-specified endpoint.

“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.”

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“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 L. Friedman, M.D., 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.”

CENTAUR demonstrated that significantly more patients treated with CVC for one year saw an improvement in fibrosis by at least one stage without worsening of steatohepatitis compared to placebo (intent-to-treat population; 20% vs 10%, p=0.02). CVC showed anti-fibrotic activity across all three stages of fibrosis (F1-F3) as measured in this key secondary endpoint. The study did not meet the other key secondary endpoint, which was complete resolution of steatohepatitis. Patients remain on therapy in a blinded fashion and all endpoints will be evaluated again at year two of the study with a liver biopsy. All baseline and year one biopsies have been read in a blinded fashion as to study drug assignment by a central pathologist. The safety profile of CVC was comparable to placebo. The most commonly reported drug-related clinical adverse events of at least moderate severity in the CVC arm were fatigue (2.8%) and diarrhea (2.1%). Tobira plans to present detailed results from the CENTAUR study at a major upcoming medical conference.

Regulators have identified ‘improvement in fibrosis by at least one stage without worsening of steatohepatitis,’ or ‘complete resolution of steatohepatitis without worsening of fibrosis’ as two endpoints to support a marketing application. Achieving a two-point reduction in the NAFLD Activity Score is not considered a registrational endpoint.

“We designed the CENTAUR trial to explore a number of registrational and non-registrational endpoints and achieved...


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