Congratulations to Ipsen on positive Phase IIIb results from the ELSPIRE trial evaluating IQIRVO® (elafibranor) in patients with Primary Biliary Cholangitis (PBC).
The trial met its primary endpoint with statistical significance, with 85% of patients treated with IQIRVO achieving ALP normalization versus 23% on placebo — a result with meaningful implications for how the field approaches treatment goals in PBC.
Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, Velocity Senior Scientific Advisor, Medical Director, and Principal Investigator, was quoted in the announcement: “We now recognize that patients who maintain normal serum alkaline phosphatase (ALP) have the best outcomes in PBC; therefore, our treatment goals are evolving to aim for ALP normalization as the optimal treatment target for this progressive and chronic liver disease. These data from the ELSPIRE trial show that ALP normalization is an achievable goal for patients with PBC.”
Congratulations to Ipsen, Dr. Kowdley, the research teams, and the patients who participated in this important study.
Read the full press release: https://www.ipsen.com/press-release/iqirvo-demonstrates-statistically-significant-improvement-in-alp-normalization-in-patients-with-pbc-in-phase-iiib-elspire-study-3325891
