ICPT - Intercept updates Phase 3 data for the NASH candidate

Intercept Pharmaceuticals ( NASDAQ: ICPT ) announced Monday additional data from its pivotal Phase 3 study for obeticholic acid (OCA) designed to target patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH).

A previous readout from the trial named REGENERATE indicated that the OCA, already approved in the U.S. as Ocaliva for primary biliary cholangitis (PBC), met the primary endpoint of the study, which is currently underway with the participation of 2,480 subjects.

According to the latest data, in the group for advanced fibrosis without cirrhosis (F3 fibrosis at baseline) (n=520), those who received OCA 25 mg showed an improvement in fibrosis by at least 1 stage without NASH worsening compared to 9.5% in the placebo (p=0.0001).

In the group with F2 fibrosis at baseline (n=411), 18.7% of those who received that OCA dose improved fibrosis by at least 1 stage without worsening of NASH compared to 9.9% in the placebo group. (p<0.04).

Regarding tolerability, based on 2,477 subjects, pruritus (24% in placebo, 33% in OCA 10 mg, 55% in OCA 25 mg) was the most common treatment-emergent adverse event and the leading cause for treatment discontinuation.

Intercept ( ICPT ) is on track to refile its marketing application for OCA in liver fibrosis due to NASH by the end of the year.

The July readout from REGENERATE showed that 22.4% of subjects who received OCA at 25 mg achieved at least one stage of fibrosis improvement with no worsening of NASH at month 18 compared to 9.6% on placebo (p<0.0001).

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