Conatus Pharmaceuticals Inc (NASDAQ:CNAT) is advancing its lead compound, named as emricasan, for the treating patients with chronic liver disease.
The firm recently initiated ENCORE-PH, which is a randomized, placebo-controlled, double-blind Phase IIb clinical study commenced in November 2016 assessing the impact of emricasan in minimizing hepatic venous pressure gradient in subjects with early decompensated or compensated liver cirrhosis led by nonalcoholic steatohepatitis, and severe portal hypertension validated by HVPG of ≥12 mmHg at starting point. Report after 24 weeks of treatment administered twice in a day with placebo or emricasan is expected in 2018.
The highlights
Conatus has two added ongoing emricasan Phase IIb clinical studies, POLT-HCV-SVR and ENCORE-NF. POLT-HCV-SVR is a randomized, placebo-controlled, double blind Phase IIb clinical study commenced in May 2014 assessing prospective improvements in Ishak Fibrosis Score in POLT recipients with cirrhosis or liver fibrosis post-transplant as an outcome of recurrent hepatitis C virus infection who have successfully attained a sustained viral response following HCV antiviral treatment. Report after 2-years of treatment administered twice in a day with placebo or emricasan is expected in 1H2018.
ENCORE-NF is a randomized, placebo-controlled, double blind Phase IIb clinical study commenced in January 2016 assessing prospective improvements in steatohepatitis and fibrosis in subjects with fibrosis resulted by NASH. Report after 18-months of treatment administered twice in a day with placebo or emricasan is expected in 2018.
Conatus intends to initiate the additional emricasan clinical studies as resources permit. One of those studies is ENCORE-LF, which is a planned randomized, placebo-controlled, double-blind clinical study, expected to commence in 1H2017, to assess the impact of emricasan on liver function and to gather chronic administration safety data in NASH cirrhosis patients.
Next study in this list is ENCORE-XT. Planned extensions to continue cure for a total of minimum two years in subjects completing the ENCORE-LF and ENCORE-PH trials, with continuous monitoring for safety, efficacy, clinical results and health-related quality of life.
