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Another Disappointment In NASH Research - CNAT Plunges On Trial Failure


Yet another potential treatment for non-alcoholic steatohepatitis, or NASH, has failed in clinical testing, adding one more to the list of flops in the NASH drug space.

Conatus Pharmaceuticals Inc.'s (CNAT) Emricasan has failed to meet the primary endpoint in a phase IIb trial in patients with biopsy-confirmed nonalcoholic steatohepatitis and liver fibrosis, dubbed ENCORE-NF.

Non-alcoholic steatohepatitis, which refers to liver inflammation due to fat buildup in the liver, is said to affect an estimated 16 million Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD. The incidence of NASH is on the rise, and even worrying is the fact that there are no approved treatments for the disease, yet.

The ENCORE-NF trial's primary endpoint was a =1 CRN fibrosis stage improvement with no worsening of steatohepatitis compared with placebo at week 72, which was not met.

ENCORE-NF is one of three phase IIb clinical trials conducted by Conatus in collaboration with Novartis, designed to evaluate Emricasan in patients with fibrosis or cirrhosis caused by NASH. The other two trials are ENCORE-PH, evaluating Emricasan in patients with NASH cirrhosis and severe portal hypertension, and ENCORE-LF, evaluating Emricasan in patients with decompensated NASH cirrhosis.

Last December, the Company announced that the ENCORE-PH trial did not meet the primary endpoint. The study has an ongoing six-month extension with 48-week liver function. Results following the extension period in ENCORE-PH trial are expected in mid-2019. Top-line results from ENCORE-LF are expected in mid-2019.

Last month, Gilead Sciences Inc. (GILD) announced that its phase III study of Selonsertib in patients with compensated cirrhosis due to NASH, dubbed STELLAR 4, did not meet the pre-specified week 48 primary endpoint.

CNAT closed Thursday's trading at $2.91, up 1.04%. In after-hours, the stock was down 50.86% to $1.43.

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