Liver Biopsy Data from POISE Phase 3 Substudy Supports Obeticholic Acid’s Ability to Reverse or Stabilize Fibrosis and Cirrhosis in Primary Biliary Cholangitis (PBC) Patients

Intercept Pharmaceuticals (Nasdaq:ICPT) a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced clinical data from a liver biopsy-based substudy from the POISE Phase 3 trial suggesting that long-term OCA treatment in patients with PBC was associated with reversal or stabilization of fibrosis and cirrhosis.

As quoted in the press release:

“In this small but important study, some patients treated with OCA had regression of fibrosis and even cirrhosis. This is a significant finding because it further supports the clinical relevance of the biochemical improvements that predict the medication’s impact on disease progression and clinical outcomes,” said lead author Christopher Bowlus, M.D., University of California, Davis. “We look forward to the results of the Phase 4 COBALT study to further evaluate OCA’s effects on fibrosis regression and clinical outcomes in patients with PBC.”

OCA is not currently indicated for the reversal of fibrosis or cirrhosis in patients with PBC.

Prior longitudinal biopsy studies have shown that patients who are not treated with, or have an inadequate response to, ursodeoxycholic acid (UDCA), the current standard of care, are at significantly higher risk of fibrosis progression, liver failure, transplant and death. Liver biopsy is not the standard of care in PBC and difficult to obtain in clinical trials. In this voluntary substudy of the POISE Phase 3 trial, paired biopsies adequate for analysis were obtained for 13 patients, all of whom had liver fibrosis or cirrhosis at baseline.

Click here to read the full press release.