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Conatus Achieves Positive Results with Emricasan in Initial Stage of Phase 2 Liver Cirrhosis Clinical Trial

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Management Comment "With these latest results, we have now demonstrated emricasan's ability to cause meaningful improvements in targeted patient populations using all three measures identified by the FDA (U.S. Food and Drug Administration) as potentially acceptable surrogate endpoints for clinical trials in patients with liver cirrhosis," said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. "The evidence of emricasan's clinical activity across the spectrum of liver disease continues to build. Over the past year, we have generated clinical data defining acceptable emricasan dosing in patients with all levels of liver function impairment, and confirming that emricasan is active across multiple etiologies of liver disease. The two latest clinical trials demonstrate emricasan's ability to provide statistically significant improvements rapidly in clinically important validated surrogate endpoints of portal hypertension and liver function in the subgroups of patients with highest medical need. These results reinforce our commitment to the further development of emricasan with a focus on an initial registration in liver cirrhosis. We believe the planned ENCORE liver cirrhosis and nonalcoholic steatohepatitis (NASH) fibrosis clinical trials announced in November offer the optimal path forward toward that objective. We expect that the upcoming six-month Liver Cirrhosis clinical trial data will allow us to determine, with the continued engagement of the regulatory authorities, whether the ENCORE-LF clinical trial — originally planned as a Phase 2 clinical trial — may be redesigned to qualify as Phase 3. We are advancing well with our plans to initiate the ENCORE clinical trials on a staggered basis through early 2017."
http://ir.conatuspha...
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Occurred on:
Jan 05, 2016
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Related Keywords Emricasan, Liver Function, Phase 2, Liver Cirrhosis, Caspase-cleaved Cytokeratin 18, Meld, Child-pugh-turcotte, Portal Hypertension