Conatus Pharma's liver drug succeeds in mid-stage study, shares soar

Last Updated: 2015-03-26

By Reuters Staff

(Reuters) - Conatus Pharmaceuticals Inc said its experimental lead drug was more effective than a placebo in a phase 2 study in patients with non-alcoholic fatty liver disease.

The company's stock soared more than 50% before the bell on Thursday.

The drug emricasan is a first-in-class, orally active pan-caspase protease inhibitor. It was tested in 38 patients with non-alcoholic fatty liver disease, including some with non-alcoholic steatohepatitis (NASH), a more severe form of the condition, the company said.

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, the company said.

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 treatment had no adverse effects on lipid levels or insulin sensitivity in these patients, who are typically at risk of cardiovascular disease, Conatus said.

Emricasan is Conatus' most advanced drug-in-development and is designed to interrupt disease progression across the spectrum of liver disease.

The treatment, which is being tested for multiple liver indications, is initially being developed for liver cirrhosis, or severe scarring that may be caused by all manner of assaults on the liver.

Conatus estimates that about 2 million people in the United States and five largest European markets have cirrhosis and varying degrees of liver impairment.