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New analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULN
Findings suggest that OCA has the potential to reduce the liver biomarker GGT, in addition to well-known effects on ALP, below thresholds that predict improved outcomes, including survival, in PBC
Data to be featured in poster presentation on Monday, November 13
MORRISTOWN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly-owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new data from a sub-analysis of the landmark Phase 3 POISE trial evaluating the impact of obeticholic acid (OCA) on achievement of gamma-glutamyl transferase (GGT) <3.2×upper limit of normal (ULN) and alkaline phosphatase (ALP) <1.5×ULN for the treatment of primary biliary cholangitis (PBC). This analysis suggests OCA's potential to reduce GGT, in addition to the well-known effects on ALP levels, below the biochemical thresholds that are prognostic for worsening clinical outcomes. These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting® in Boston.
"These new data demonstrate the potential of OCA to reduce GGT, in addition to the already established effect on ALP levels, which have been shown to be predictive of risk of liver transplantation or death in patients with PBC," said M. Michelle Berrey, M.D., M.P.H., President of Research & Development and Chief Medical Officer of Intercept. "With the increasing evidence of improved event-free survival for patients treated with OCALIVA across different studies, it was important to improve our understanding of OCALIVA's impact on different biochemical markers and how that correlates with improved outcomes. We are pleased to join clinicians, researchers and industry peers at The Liver Meeting® 2023 to share these data that reaffirm the need for comprehensive assessment of treatment response beyond ALP when managing patients with PBC."
In the study, patients with PBC who were receiving a stable dose of ursodeoxycholic acid (UDCA) or who were unable to tolerate UDCA were randomized to receive placebo, OCA 5-10 mg (OCA titration), or OCA 10 mg daily. For the OCA 5-10 mg group, OCA 5 mg was titrated to 10 mg at 6 months based on tolerability and biochemical response. A 12-month double-blind (DB) period was followed by a 5-year optional open-label extension (OLE), in which all patients were initially treated with OCA 5 mg daily for the first 3 months; every 3 months thereafter, patients had the option to increase the dose up to 10 mg. Serum GGT and ALP levels were assessed at baseline and every 3 months through the 5-year follow-up.
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:
"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.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death.
About Ocaliva® (obeticholic acid)
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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