Core Insights - Ipsen announced new data on IQIRVO for Primary Biliary Cholangitis (PBC) from the ELATIVE trial, to be presented at The Liver Meeting 2025 [1] Group 1: Clinical Trial Results - Interim data from the ELATIVE trial showed that IQIRVO led to sustained improvements in cholestasis biomarkers and stabilization of fibrosis markers over three years in 115 patients [2] - At week 182, 72% of patients on IQIRVO maintained a biochemical response, with a 47% reduction in alkaline phosphatase (ALP) from baseline [2] - Improvements in fatigue and pruritus symptoms were consistent, with a well-characterized safety profile and no new safety signals identified [2][4] Group 2: Expert Commentary - Dr. Cynthia Levy emphasized the importance of long-term treatment data for PBC, noting that IQIRVO shows effective treatment with a reassuring safety profile [3] - Sandra Silvestri highlighted IQIRVO's potential to manage disease progression markers and improve quality of life for PBC patients [4] Group 3: Mechanistic Insights - Further analysis from the ELATIVE trial indicated a relationship between changes in fatigue-associated proteins and reported fatigue outcomes in patients treated with IQIRVO [3] - The data suggests that IQIRVO, as a PPAR α/δ agonist, may modulate pathways involved in energy metabolism and mitochondrial function, addressing fatigue in PBC patients [3][6] Group 4: Trial Design and Background - The ELATIVE trial is a Phase III, multi-center, randomized, double-blind, placebo-controlled study evaluating elafibranor 80mg once daily versus placebo for PBC patients with inadequate response to ursodeoxycholic acid (UDCA) [5] - The trial enrolled 161 patients, with ongoing open-label long-term extension [5] Group 5: Product Information - IQIRVO (elafibranor) is an oral PPAR agonist that improves cholestasis and has anti-inflammatory effects, granted Breakthrough Therapy Designation by the FDA in 2019 [7] - It received accelerated approval from the FDA in June 2024 and conditional approval from the EMA and UK MHRA in late 2024 for treating PBC [7] Group 6: Disease Context - Primary Biliary Cholangitis is a rare autoimmune liver disease affecting approximately 100,000 people in the US and 165,000 in Europe, primarily women [8]