March 26, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO -- Conatus Pharmaceuticals Inc.’s lead drug emricasan, used for treatment in non-alcoholic fatty liver disease (NAFLD), was highly effective in a Phase II double-blind placebo-controlled clinical trial, the company announced Thursday morning, which pushed the company’s stock up more than 44 percent in Thursday trading.
News of the success of the trial has sent Canatus’ stock soaring this morning, jumping more than $2.60 to trade as high as $8.35 per share this morning. The stock closed at $5.76 per share on Wednesday.
Emricasan was tested in 38 patients with non-alcoholic fatty liver disease, including some sufferers of nonalcoholic steatohepatitis (NASH), a more severe form of the condition, the company said in a press release. Nonalcoholic fatty liver disease is a term used to describe the accumulation of fat in the liver of people who drink little or no alcohol, according to the Mayo Clinic. In some people with NAFLD, the fat that accumulates can cause inflammation and scarring in the liver, which is diagnosed as NASH.
At its most severe, nonalcoholic fatty liver disease can progress to liver failure. Currently there is no standard treatment for nonalcoholic fatty liver disease exists. Conatus estimates that about two million people in the United States and across Europe have cirrhosis and varying degrees of liver impairment.
To date, emricasan has been studied in over 550 subjects in fourteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease, the company said.
During the NAFLD/NASH trial emricasan was shown to be safe and well tolerated, with no dose-limiting toxicities and no drug-related serious adverse events, the company said. Emricasan also had no adverse effects on lipid levels or insulin sensitivity, important safety assessments in NAFLD/NASH patients who are at risk for cardiovascular disease.
“With these results from the NAFLD/NASH trial, we have confirmed that the optimal dose of emricasan is consistent across different etiologies,” Conatus Co-Founder, President and Chief Executive Officer Steven J. Mento said in a press release, “and strengthened our belief that inhibiting excessive apoptosis and inflammation will be therapeutic in patients whose liver damage is associated with NASH.”
Following the results of the Phase II trial, the company said it is prepared to seek guidance from regulatory authorities on the “appropriate use and analysis of these endpoints in registrational trials including patients with NASH cirrhosis.”
Conatus’ focus is on developing emricasan as a treatment in patients with liver cirrhosis. Several drugmakers, including Gilead Sciences, Inc. , Intercept Pharmaceuticals and France’s Genfit SA, are attempting to develop treatments for NASH, Reuters reported this morning.
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