Tobira Therapeutics, Inc. (NASDAQ:TBRA) has finally revealed on Monday the results of the Phase 2b safety and efficacy clinical trial for cenicriviroc (CVC) treating non-alcoholic steatohepatitis (NASH) among 289 patients suffering from liver fibrosis, a study that is also known as CENTAUR.
The study failed to meet its main endpoint but it did meet one of its secondary endpoints, showing a meaningful improvement in liver fibrosis of at least one stage in just a year. CENTAUR is the first randomized clinical trial to pre-specify this as an endpoint. According to regulators, this is necessary for the commercialization of CVC as a NASH treatment.
The other secondary endpoint involves the entire resolution of NASH, which CENTAUR did not meet as well, to back the marketing application of CVC.
Laurent Fischer, M.D., Tobira Therapeutics CEO, elaborated that CENTAUR was designed to explore various possibilities— whether registrational or non-registrational in nature. Consequently, Fischer ensured confidence, saying that the results actually exceeded the company’s expectations.
CVC for Liver Fibrosis
According to Scott Friedman, M.D., CENTAUR Study Chairman and Icahn School of Medicine Chief of Liver Diseases Division, noted that the safety— which can be compared to the safety of placebo— and efficacy data of CVC indicates its potentials to treat liver fibrosis relating to NASH. It is a potentially significant breakthrough given that there are no approved treatments yet for a disease with growing number of cases.
Across all three liver fibrosis stages, CVC has demonstrated antifibrotic activities, meeting an important secondary study endpoint.
Fischer said that Tobira Therapeutics is preparing to meet with regulators later this year in line with the Phase 3 of the study, which is expected to conclude the evaluation of the safety and efficacy of the antifibrotic activity of CVC by 2017. Moreover, the company is also hoping to launch a Phase 1 clinical trial of CBC combined with evogliptin by the end of the year.
On Monday, Levi & Korsinsky LLP began investigating the company in the light of allegations suggesting that Tobira Therapeutics and some of its officers are involved in federal violations.