Conatus Soars on Positive Phase II Data on Emricasan – Analyst Blog
Conatus Pharmaceuticals CNAT announced top-line results from a phase II double-blind, placebo-controlled study (n=38) on emricasan, in patients with nonalcoholic fatty liver disease (NAFLD), including a subset of NAFLD patients with nonalcoholic steatohepatitis (NASH).
Results showed a statistically significant reduction in alanine amino transferase (ALT) in patients treated with emricasan (25 mg twice daily) compared to placebo (39% versus 14%). Emricasan-treated patients also achieved a statistically significant reduction on elevated baseline levels of three key serum biomarkers: caspase-cleaved cytokeratin 18 (cCK18), full length cytokeratin 18 and caspase 3/7. The candidate was found to be safe and well-tolerated with no dose-limiting toxicities or serious adverse events being reported.
The company expects to present detailed results from the NAFLD/NASH study at the annual meeting of the European Association for the Study of the Liver in April.
According to the National Institutes of Health, approximately 5.5 million people in the U.S. suffer from chronic liver disease, or cirrhosis. Additionally, the European Association for the Study of the Liver estimates 29 million people in the EU to be suffering from the same disease.
Apart from the NAFLD/NASH study, Conatus is evaluating emricasan in other studies, which include a liver cirrhosis study (phase II, initial results expected in the fourth quarter of 2015), a portal hypertension (PH) study (phase II, top-line results expected in the third quarter of 2015) and a post liver transplant clearance of hepatitis C virus infection with sustained viral response (POLT-HCV-SVR) study (phase IIb, initial results expected in the second quarter of 2015).
We are encouraged by Conatus’ efforts to develop emricasan for different types of liver diseases and expect investor focus to remain on further updates. Shares were up 17.4% on the positive top-line data.