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Reuters Health Information: Intercept's drug for liver fibrosis due to NASH meets main goal

Intercept's drug for liver fibrosis due to NASH meets main goal

Last Updated: 2019-02-19

By Ankur Banerjee and Manas Mishra

(Reuters) - Intercept Pharmaceuticals Inc said on Tuesday its treatment in patients with nonalcoholic steatohepatitis (NASH) showed an improvement in liver fibrosis, taking the drug a step closer to approval.

The drug, obeticholic acid (OCA), was tested in non-cirrhotic patients with stage 2 or 3 fibrosis.

The late-stage study found that a once-daily higher dose of 25 mg met the main goal of fibrosis improvement with no worsening of NASH after 18 months.

"The topline data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH," Chief Executive Officer Mark Pruzanski said in a statement.

Gilead Sciences Inc said last week that a late-stage study of its experimental drug aimed at treating NASH failed to meet its main goal.

Jefferies analyst Michael Yee called Intercept's data strong. "We believe this is essentially a near best case scenario and expect the stock to be up significantly."

More patients in the two dosage arms achieved NASH resolution with no worsening of liver fibrosis compared with a placebo, but the differences were not statistically significant.

Analysts said the main goal of fibrosis improvement was likely more important for an approval as well as potential use.

Intercept said it intends to file for regulatory approval in the United States and Europe in the second half of 2019.

While there were no major surprises to OCA's safety profile or red flags, pruritis was on the higher end of what was observed in prior studies, RBC Capital Market analyst Brian Abrahams wrote in a client note.

The company said some patients with pruritis discontinued the trial as required by the trial design.

The drug, marketed as Ocaliva, is already approved at a much lower once-weekly dose for patients with primary biliary cholangitis. In that population, a black box warning notes that hepatic decompensation and failure, in some cases fatal, have been reported in patients with PBC with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when Ocaliva was dosed more frequently than recommended.

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