Obeticholic acid (OCA; Ocaliva) was found to improve fibrosis in 46% of patients with primary biliary cholangitis (PBC), according to findings from a small, biopsy-based substudy of the POISE Phase 3 trial. The full results are being presented at the International Liver Congress 2018, in Paris.
A total of 216 patients were enrolled in POISE and randomized to receive either placebo, OCA 5mg titrated to 10mg or OCA 10mg, while 93% also continued to take ursodeoxycholic acid (UDCA). After 6 months, the 5mg group was titrated to 10mg with treatment lasting for 3 years. Paired biopsies adequate for analysis were obtained from 13 patients who took part in the voluntary substudy.
Results showed that 46% (n=6) of substudy patients improved their histological fibrosis stage, while 38% maintained (n=5), and 15% experienced 1 stage progression (n=2).
“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, MD, University of California, Davis.
Obeticholic acid is not currently approved for the reversal of fibrosis or cirrhosis in patients with PBC. The Company is in the process of investigating OCA’s effects on fibrosis regression in a Phase 4 study, COBALT.
Obeticholic acid (Ocaliva; Intercept Pharmaceuticals) is approved in the U.S. to treat PBC in combination with ursodexycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
For more information visit Intercept.com.