Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced top-line results from the company's Phase 2 double-blind, placebo-controlled clinical trial of emricasan, a first-in-class, orally active pan-caspase protease inhibitor, in 38 patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH). The trial met its primary endpoint, showing a statistically significant (p < 0.05) reduction in alanine amino transferase (ALT) in patients treated for 28 days with emricasan at 25 mg twice per day dosing compared to patients in the placebo control group. Reductions from baseline in ALT at Day 28 of approximately 39% in the emricasan treatment arm and approximately 14% in the placebo arm were similar to results observed in previous trials. Elevated baseline levels of three key serum biomarkers – caspase-cleaved cytokeratin 18 (cCK18), full length cytokeratin 18, and caspase 3/7 – also showed statistically significant reductions from baseline in emricasan-treated patients at Day 28. The baseline elevation in cCK18 confirmed that the underlying targets of emricasan's mechanism, apoptosis and inflammation, which are believed to drive liver disease progression, were engaged in the NAFLD/NASH patients in this trial. A reduction from baseline in cCK18 at Day 28 of approximately 30% in the emricasan treatment arm and an increase from baseline of approximately 4% in the placebo arm were similar to results observed in previous trials. The reduction in serum cCK18 levels demonstrated that emricasan can effectively reduce inflammation and elevated levels of apoptosis in NAFLD/NASH patients. These results were consistent with data obtained from the company's previous clinical trials in other liver disease patient populations.
Emricasan was safe and well tolerated in the NAFLD/NASH trial, with no dose-limiting toxicities and no drug-related serious adverse events. Treatment with 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. Detailed results from the NAFLD/NASH trial will be presented in a late-breaker poster at The International Liver Congress™ 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 22-26, 2015.
"With these results from the NAFLD/NASH trial, we have confirmed that the optimal dose of emricasan is consistent across different etiologies," said Conatus co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., "and strengthened our belief that inhibiting excessive apoptosis and inflammation will be therapeutic in patients whose liver damage is associated with NASH."
"Our focus is on developing emricasan initially as a treatment in patients with liver cirrhosis," said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. "The data from the NAFLD/NASH trial, along with the data from our three organ impairment dosing trials, support the conduct of efficacy trials in patients with liver cirrhosis due to NASH. In addition, the recently published proceedings of a 2013 NASH endpoints workshop sponsored by the American Association for the Study of Liver Diseases (AASLD) and U.S. Food and Drug Administration (FDA) provided important insights regarding validated surrogate clinical endpoints that could be useful for accelerated approval pathways in patients with NASH-driven liver cirrhosis. With this comprehensive information package, we are prepared for planned discussions with regulatory authorities to seek guidance on the appropriate use and analysis of these endpoints in registrational trials including patients with NASH cirrhosis."
About Emricasan Clinical Development
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. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. (Original Source)
Shares of Conatus closed yesterday at $5.76 . CNAT has a 1-year high of $11.74 and a 1-year low of $5.06. The stock's 50-day moving average is $6.06 and it's 200-day moving average is $6.75.
On the ratings front, Conatus has been the subject of a number of recent research reports. In a report issued on March 17, Roth Capital analyst Ed Arce resumed coverage with a Buy rating on CNAT and a price target of $15, which implies an upside of 160.4% from current levels. Separately, on March 12, Stifel Nicolaus' Stephen Willey reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ed Arce and Stephen Willey have a total average return of 24.4% and 33.4% respectively. Arce has a success rate of 41.1% and is ranked #254 out of 3547 analysts while Willey has a success rate of 64.2% and is ranked #35
Conatus Pharmaceuticals Inc is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease.