Phase III ELSPIRE Trial Shows Elafibranor Normalizes Alkaline Phosphatase in Primary Biliary Cholangitis Patients

Results from the phase III randomized controlled ELSPIRE trial indicate that treatment with elafibranor significantly normalized alkaline phosphatase (ALP) levels in patients with primary biliary cholangitis (PBC) who had an incomplete response to ursodeoxycholic acid (UDCA). At Week 52, 85.3% of patients receiving elafibranor achieved the primary endpoint of ALP normalization, compared to 23.3% receiving placebo. This supports elafibranor as a second-line treatment for PBC patients with specific ALP levels, with ALP normalization identified as an achievable treatment goal.