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Tuesday, February 19, 2019

-=Intercept Pharma (ICPT) : 'positive' top-line results from Phase 3 REGENERATE study of obeticholic acid in patients with liver fibrosis due to NASH

Intercept Pharmaceuticals (ICPT) stock popped Tuesday after its liver disease treatment succeeded in a Phase 3 study — a week after Gilead Sciences (GILD) failed in the same area.

Both companies are targeting nonalcoholic steatohepatitis, a liver disease known as NASH.

Early Tuesday, Intercept said its drug, Ocaliva, improved liver damage called fibrosis without worsening the symptoms of NASH after 18 months of treatment.

"We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years," Intercept Chief Executive Mark Pruzanski said in a written statement.

Based on the results, Intercept plans to file for approval of Ocaliva in NASH treatment in the U.S. and Europe in the second half of 2019.

NASH Treatment Succeeds In Stage 2-3 Patients
Intercept's test included 931 patients with stage 2 or state 3 liver fibrosis due to NASH. The worst level of fibrosis is stage 4.

Researchers tested two doses of Ocaliva. At the low dose, 17.6% of patients showed fibrosis improvement without worsening NASH. The higher dose netted 23.1% of patients with the same result. Just 11.9% of the placebo group had the same result.

The biotech also tested Ocaliva as a NASH treatment. After 18 months, 11.2% and 11.7% of the Ocaliva patients showed no symptoms of NASH and hadn't experienced worsening in fibrosis. Just 8% of placebo patients had the same result.

The NASH treatment results weren't statistically significant, Intercept said. But the Food and Drug Administration only required the study to meet one of its goals to be successful.

Gilead is also testing a NASH treatment in patients with stage 3 fibrosis. Last week, the drug failed in a late-stage study in patients with stage 4 fibrosis.

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