Intercept announces additional data from Phase 3 REGENERATE study

Intercept Pharmaceuticals announced additional supportive data from its pivotal Phase 3 REGENERATE study of obeticholic acid, OCA, in patients with liver fibrosis due to nonalcoholic steatohepatitis, NASH. These analyses further demonstrate OCA’s consistent and well-defined antifibrotic effect as well as its monitorable and manageable safety and tolerability profile in patients with liver fibrosis due to NASH. Interim Efficacy Analysis: As previously reported in July 2022, in a second interim analysis of the ITT population from REGENERATE, 22.4% of subjects randomized to once-daily oral OCA 25 mg met the primary endpoint of achieving at least one stage of fibrosis improvement with no worsening of NASH at Month 18 on liver biopsy compared with 9.6% of subjects on placebo. Additional Supportive Efficacy Analyses: Additional efficacy analyses conducted in the ITT population reinforced consistent antifibrotic effect, showing: Antifibrotic effect was more pronounced in individuals with advanced fibrosis without cirrhosis at baseline, with 25.4% of patients in the OCA 25 mg group demonstrating an improvement in fibrosis by at least 1 stage without worsening of NASH as compared to 9.5% in placebo; and In individuals with F2 fibrosis at baseline, 18.7% of patients in the OCA 25 mg group demonstrated an improvement in fibrosis by at least 1 stage without worsening of NASH as compared to 9.9% in placebo. Safety and Tolerability: Safety was evaluated in 2,477 subjects who took at least one dose of study drug. Treatment-emergent adverse events, treatment-emergent serious adverse events, and deaths were generally balanced across the OCA and placebo treatment groups. The most common TEAE was pruritus and pruritus was the most common cause for treatment discontinuation.