Ipsen Presents New Data Reinforcing IQIRVO® in PBC at EASL 2026

Ipsen unveiled late-breaking data at the European Association for the Study of the Liver (EASL) Congress 2026 showing that IQIRVO® (elafibranor) improved fatigue, pruritus, and alkaline phosphatase (ALP) levels in patients with primary biliary cholangitis (PBC). The findings included new analyses from the Phase III ELATIVE trial, interim data from the Phase IV ELFINITY study, and real-world evidence from a U.S. database analysis.

The data further position IQIRVO as the only second-line PBC therapy with evidence supporting rapid and robust ALP reduction alongside improvements in fatigue and pruritus.

Dual PPAR Agonist Activity

IQIRVO is a once-daily oral dual agonist of PPAR α and PPAR δ. By modulating bile acid synthesis, detoxification, and transport pathways, the therapy reduces bile toxicity and cholestatic injury. It also exerts anti-inflammatory and anti-fibrotic activity.

PBC is a chronic autoimmune liver disease characterized by progressive destruction of intrahepatic bile ducts. Persistent cholestasis can lead to fibrosis, cirrhosis, liver failure, and premature death, while fatigue and pruritus remain among the most burdensome symptoms despite standard treatment with ursodeoxycholic acid (UDCA).

ELATIVE Trial Shows Fatigue Improvement

A post hoc analysis of the Phase III ELATIVE trial (NCT04526665) showed that 67% of patients with moderate-to-severe baseline fatigue achieved clinically meaningful improvement with IQIRVO compared with 31% on placebo (p=0.020).

Benefits emerged as early as Week 4 and were sustained through 52 weeks. Fatigue was assessed using the PROMIS Fatigue Short Form 7a, with improvements observed across multiple symptom domains, including extreme exhaustion, mental clarity, and daily functioning. Improvements were also reported in patients feeling too tired to think clearly and too fatigued to perform routine activities such as bathing or showering.

David Jones, Professor of Liver Immunology at Newcastle University, said the findings address a major unmet need in PBC, where fatigue remains difficult to manage despite currently available therapies.

Real-World and Phase IV Data Support ALP Reduction and Symptom Relief

In a U.S. HealthVerity database analysis, 72% of second-line treatment-naïve patients achieved at least a 15% reduction in ALP by Month 6, while 59% achieved ALP normalization.

Mean ALP levels declined from 174 U/L to 131 U/L during the study period. ALP normalization is recognized as an important surrogate marker associated with improved long-term outcomes and transplant-free survival in PBC.

Interim Month 3 findings from the global Phase IV ELFINITY study (NCT06447168) also showed rapid and sustained ALP reductions, with biochemical response achieved in 55% of patients. More than half of patients with moderate-to-severe baseline fatigue reported clinically meaningful improvement, alongside reductions in pruritus.

The tolerability profile remained consistent with previous studies, with no serious or severe treatment-emergent adverse events reported.

Regulatory Expansion and Global Reach

IQIRVO received accelerated approval from the U.S. Food and Drug Administration in 2024 and conditional approvals in Europe and the UK for adults with PBC who are inadequately responsive or intolerant to UDCA. The therapy is also approved in Canada, Australia, Brazil, and several additional international markets.

Ipsen licensed global rights to elafibranor from GENFIT in 2021 and expanded the agreement to include China, Hong Kong, Taiwan, and Macau in 2026.

Sandra Silvestri, MD, PhD, Ipsen’s Chief Medical Officer, said the growing body of clinical and real-world evidence reinforces IQIRVO’s ability to address both cholestatic disease progression and symptom burden in PBC.

Reference

New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC