Intercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting 2023 - Seite 2

Hepatocyte injury causes GGT to be released into the blood. Elevated GGT in the setting of elevated ALP and other liver enzyme abnormalities is a marker for hepatobiliary disorder. The goal of this sub-analysis was to evaluate the proportion of patients receiving OCA who achieved and sustained GGT <3.2×ULN and ALP <1.5×ULN. Results include:

• In the double-blind (DB) intent-to-treat population (N=203), the proportion of responders was significantly greater at each time point in both OCA cohorts compared with placebo, with the highest responder rates observed in the OCA 10 mg group.
• In the OCA titration group, 17% (11/66) were responders at DB Months 9 and 12. In the OCA 10 mg group, the highest responder rate was observed at DB Month 9 (31% [21/68]), followed by DB Month 12 (26% [18/68]).
• In the open-label extension (OLE) intent-to-treat population (N=119), the proportion of responders generally increased over time, ranging from 18% (22/119) at OLE Month 3 to 38% (35/91) at OLE Month 51. At OLE Month 60, 37% (17/46) were responders.
  

“A recent study from the Global PBC study group showed that GGT ≥3.2xULN and ALP≥1.5xULN increase the risk of liver transplantation or death in patients with PBC,” said Robert G. Gish, M.D. FAASLD, Professor at Loma Linda University Department of Medicine. “This new analysis shows that OCA can reduce and maintain GGT and ALP levels below these thresholds over a 6-year period, adding to an already substantial body of evidence supporting OCA’s potential to decrease the risk of progression to liver transplant or death in patients with PBC.”

Poster Presentation
“Effect of Obeticholic Acid on Prognostic Thresholds of Gamma-Glutamyl Transferase and Alkaline Phosphatase Levels: Sub-analysis of the Phase 3 POISE Trial in Primary Biliary Cholangitis” Poster #4545-C
Monday, November 13, 1-2 PM ET
Alan Bonder, Darren Wheeler, Radhika Nair, Erik Ness, Elizabeth S. Malecha and Robert G. Gish

A full list of sessions at The Liver Meeting 2023 is available at https://www.aasld.org/the-liver-meeting.

About the POISE Trial

The POISE trial studied the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who were unable to tolerate, ursodeoxycholic acid (UDCA). There were 217 patients randomized to one of three groups in the trial: placebo, OCA 10 mg, or OCA 5 mg for six months titrated to 10 mg based on clinical response. Seven subjects did not participate in the open-label extension and were not included in the current study. Patients completing the double-blind phase had the option to continue in an open-label extension (OLE) phase for a maximum of five additional years, during which all patients received treatment with OCA 5-10 mg once daily. Of the 198 patients who completed the double-blind phase, more than 95 percent continued in the long-term safety extension phase of the trial for up to 5 years. Additional information regarding the POISE trial can be found on the NIH clinical study listing website: http://clinicaltrials.gov/ct2/show/NCT01473524.