Intercept Presents Data form Ph III Substudy That Supports Obeticholic Acid’s Ability to Reverse or Stabilize Fibrosis and Cirrhosis in Primary Biliary Cholangitis (PBC) Patients

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), 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. The data are being presented at the International Liver Congress™ 2018, the 53rd Annual Meeting of the European Association for the Study of the Liver (EASL), in Paris, France, from April 11-15, 2018.

After three years of treatment with OCA, the majority of patients improved (n=6, 46%) or maintained (n=5, 38%) histological fibrosis stage, while two patients (15%) experienced one stage progression. Of the four patients with cirrhosis at baseline, all showed reversal by at least one stage, and three (75%) improved to fibrosis without cirrhosis.

“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.”

Adverse events have been a concern with OCA. Pruritus is the most common symptom in patients with PBC and was also the most common adverse event in the POISE Phase 3 substudy. Nine (69%) patients experienced pruritus in the substudy, an incidence consistent with the rate observed in the broader study population. A total of five serious adverse events in five patients were reported. All serious adverse events were considered unlikely to be related, or not related, to OCA.