July 25, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO – Shares of Tobira Therapeutics have plunged more than 57 percent after the company’s mid-stage trial for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases, failed to meet its primary endpoint.
However, Tobira said it plans to move forward with the study because its experimental drug, cenicriviroc (CVC) showed a clinical and statistical improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after only one year of treatment. The study showed patients treated with CVC for one year saw an improvement in fibrosis by at least one stage without worsening of steatohepatitis compared to placebo. That kind of success was something regulators were looking for in order for the company to proceed to a Phase III trial, Tobira said in a statement. The company plans to initiate a Phase III study next year, with a focus on CVC’s fibrosis efficacy.
Scott Friedman, chief of the division of Liver Diseases at the Icahn School of Medicine at Mount Sinai, who oversaw the CVC trial said the fibrosis results of the drug “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.”
During a conference call with investors this morning, Tobira executives downplayed the fact CVC missed its primary goal and focused on the secondary successes, according to a report in XConomy. Laurent Fischer, chief executive officer of Tobira, said improving fibrosis may be more meaningful to patients, Xconomy reported. In a statement released earlier this morning, Laurent said the fibrosis data also gives the company rationale to develop CVC in combination with another one of its drugs, evogliptin, which he said complements CVC’s mechanism of action by targeting metabolic abnormalities. A combination trial could begin by the end of the year.
But putting the best face on things hasn’t been good enough for investors this morning. Shares of Tobira stock are trading far below Friday’s close of $11.25, with prices now at $4.78 per share.
Tobira is not the only company to work on developing treatments for NASH. Earlier this year, Gilead Sciences snapped up Cambridge, Mass.-based Nimbus Apollo, Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program in an effort to bolster the company’s pipeline for metabolic disorders and the treatment of non-alcoholic steatohepatitis (NASH). The addition of NDI-010976 will back up NASH research Gilead is conducting with its investigational monoclonal antibody simtuzumab, which was acquired from Arresto Biosciences in 2011. Gilead’s simtuzumab has had something of a troubled history, with the company ceasing several drug trials for various disorders.
Non-alcoholic steatohepatitis affects approximately 15 million people in the United States. NASH is a disease of the liver resulting from fat cells that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis.
Cenicriviroc is an oral, once-daily, immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure, the company said.
