Ipsen presents long-term IQIRVO data at liver disease conference

Ipsen (Euronext: IPN; ADR: IPSEY) announced it will present new data on IQIRVO (elafibranor) for Primary Biliary Cholangitis treatment in two late-breaking sessions at The Liver Meeting 2025, hosted by the American Association for the Study of Liver Diseases.

The interim data from the ELATIVE long-term extension trial, following 115 patients for over three years, showed that 72% of patients maintained biochemical response at week 182, with a 47% reduction in alkaline phosphatase from baseline. The study demonstrated sustained improvements in biomarkers of cholestasis and stabilization in fibrosis markers.

The trial data indicated consistent trends in improvement of fatigue and pruritus symptoms. The treatment showed a well-characterized safety profile with no new safety signals over the three-year period, according to the company's statement.

A second presentation examined the relationship between changes in fatigue-associated protein expression and reported fatigue outcomes in patients receiving IQIRVO. The analysis suggests PPAR α/δ agonist activation may modulate pathways involved in energy metabolism and mitochondrial function.

IQIRVO received U.S. FDA accelerated approval in June 2024, conditional approval by the European Medicines Agency in September 2024, and UK MHRA approval in October 2024 for treating Primary Biliary Cholangitis in combination with ursodeoxycholic acid in adults with inadequate response to UDCA, or as monotherapy for patients unable to tolerate UDCA.

Primary Biliary Cholangitis affects approximately 100,000 people in the United States and 165,000 people in Europe, with the majority being women. The autoimmune liver disease causes bile and toxin buildup and chronic inflammation leading to liver fibrosis and bile duct destruction.

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