When Tobira Therapeutics Inc. (NASDAQ: TBRA) set out to try its drug candidate cenicriviroc (CVC) on patients with non-alcoholic steatohepatitis (NASH), it hoped for positive outcome. But that was not to be and the journey the company’s shares took immediately the results of the Phase 2b study were out summed up the sentiment in the market: disappointment.
Investors don’t like disappointing news, but that was exactly what Tobira Therapeutics Inc (NASDAQ: TBRA) shared with them regarding the trial of cenicriviroc. In the Phase 2b study, Tobira set out to evaluate the safety and efficacy of efficacy of CVC in a study dubbed CENTAUR program, which enrolled 289 adult patients. The compound was evaluated against a placebo. The patients enrolled into the study were those who had been confirmed to have liver fibrosis problem.
What Tobira was aiming for in the Phase 2b study of CVC was a two-point reduction in the activity score of non-alcoholic fatty liver disease (NAFLD). The activity score is measured in a scale of zero to eight. But the results that came out of the study showed that CVC missed its primary endpoint.
All is not lost
However, it did meet one of the two secondary endpoints, which is why Tobira Therapeutics Inc. (NASDAQ: TBRA) has said that it is not discontinuing work on CVC. Instead, it will focus on developing the drug for the secondary endpoint for which it showed success during the Phase 2b trial.
As such, Tobira is hoping to return CVC to clinics in 2017 for Phase 3 trial and the management is confident that the study will be a success, thus paving the way to introduce the drug on the market. But Tobira will work closely with regulators to design the Phase 3 study of CVC, which is why the company has planned to meet with the FDA later this year.
Combination therapy – Tobira Therapeutics Inc. NASDAQ: TBRA
Besides the planned Phase 3 trial, Tobira Therapeutics Inc. (NASDAQ: TBRA) has also planned a Phase 1 trial of CVC as a combination therapy with its other compound known as evogliptin.