In the variable double-blind period of the ELATIVE Phase III trial in primary biliary cholangitis (PBC), the potential for elafibranor to improve itch-related quality of life (QoL) as measured by the itch domain of the PBC-40 and the 5-D Itch questionnaire was also demonstrated. Elafibranor is a novel, potential first-in-class, PPAR agonist. It is currently under review by the
'There are a significant proportion of people living with PBC who experience worsening disease and debilitating symptoms despite being on treatment. These long-term data from the Phase III ELATIVE study further demonstrate the potential for elafibranor to provide an effective treatment option for these patients,' said
Data presented at EASL for patients who had their week-78 double-blind visit (30 patients receiving elafibranor and 13 patients receiving placebo) demonstrated the efficacy of elafibranor was sustained after 78 weeks of treatment with 70% of patients on elafibranor meeting the composite endpoint of biochemical response versus 0% on placebo. Biochemical response was defined as alkaline phosphatase (ALP)
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