Intercept Rises After Data Shows Liver Disease Drug Works

Intercept Pharmaceuticals Inc. soared the most in about four months after releasing data showing its drug for a growing-yet-lesser-known liver disease worked.

The shares rose 17 percent to $276.52 at the close in New York, the biggest single-day jump since April 22. This year, the New York-based company’s market value has grown more than fourfold to $5.9 billion, after Intercept said in January the drug might provide a new option for patients.

The data released yesterday showed the medicine, called OCA, reversed liver damage and was safe. It’s “hard to ask for more,” said Jonathan Eckard, an analyst with Citigroup Inc., said today in a note to clients. “This is a big win for OCA, and meaningfully improves the drug’s regulatory path.”

OCA, which stands for obeticholic acid, treats nonalcoholic steatohepatitis, or NASH. The disease damages the liver in a way that looks like the livers of heavy drinkers, yet without high alcohol use. OCA reversed liver scarring, or fibrosis, which can eventually lead to organ failure or cancer, Chief Executive Officer Mark Pruzanski said on a call yesterday.

“The fibrosis benefit with OCA treatment is the first time we are aware of that a therapeutic has been shown to significantly improve liver fibrosis in a meaningful proportion of NASH patients, an unexpected and positive finding,” he said.

Liver Reversal

In a trial of 283 people with NASH, Intercept’s drug improved liver function without scarring getting worse in 46 percent of patients, compared with 21 percent on placebo, Pruzanski said. One in three patients saw liver scarring improve, almost double the rate of patients taking placebo.

NASH may be growing as obesity rates increase, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. The research agency, part of the National Institutes of Health, ran the trial, called FLINT, and stopped it in January after an analysis showed “highly statistical improvement” in patients.

Intercept plans to release full trial results Nov. 10 at the American Association for the Study of Liver Diseases meeting in Boston and is finishing its design for a Phase 3 trial, which is the last step typically needed before approval.

The company plans to target the drug first on a rare disease called primary biliary cirrhosis, in which inflammation destroys bile ducts in the liver and leads to scarring.

Cholesterol Levels

Patients who used OCA experienced “modest but statistically significant increases in total and LDL,” or bad cholesterol, and decreases in HDL, or good cholesterol, Pruzanski said.

The rise in LDL cholesterol peaked at 12 weeks, then fell over the rest of the trial. That suggests the bad cholesterol increase can be managed, Joseph Schwartz, an analyst with Leerink Partners LLC, said in a note to clients yesterday. He said he anticipates OCA will be approved in 2019.

Genfit, a French drug developer, is developing an experimental medicine, GFT505, that also treats NASH. Genfit and Intercept have said they are exploring partnerships with other drugmakers to bring their treatments to market.

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