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As previously reported in July 2022, in a second interim analysis of the ITT population from REGENERATE (n=931), 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 (p<0.0001)

Intercept Announces Additional Positive Data in Fibrosis due to NASH from New Analysis of Phase ...

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today 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)

By Intercept Pharmaceuticals, Inc.
Published - Nov 07, 2022, 08:04 AM ET
Last Updated - Apr 22, 2024, 07:00 AM EDT

OCA 25 mg demonstrated double the response rate of placebo in reduction of liver fibrosis without worsening of NASH; consistent antifibrotic effect shown across multiple analyses

OCA 25 mg showed increased antifibrotic efficacy in patients with advanced fibrosis without cirrhosis

Robust safety assessment of 2,477 patients, including 1,000 on study drug for four years, supports chronic administration of OCA

REGENERATE data to be presented in late-breaking oral session on Monday, November 7

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