VIDEO: Primary biliary cholangitis treatments poised to be clinically ‘impactful’
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BOSTON — Healio spoke with James L. Boyer, MD, about phase 3 findings from the RESPONSE trial and the ELATIVE trial and presented at The Liver Meeting.
Boyer, emeritus director of the Yale Liver Center at Yale School of Medicine, told Healio that these phase 3 trials were “probably the most impactful” studies in biliary diseases presented at the meeting.
The RESPONSE trial assessed the use of the PPAR-delta agonist seladelpar (CymaBay Therapeutics) in patients with primary biliary cholangitis (PBC) who were at risk for disease progression.
The ELATIVE trial investigated the use of the oral, dual peroxisome proliferator-activated receptor-agonist elafibranor (Genfit) in patients with PBC who had inadequate response or an intolerance to ursodeoxycholic acid.
“Overall, [the results] probably gives a slight edge to seladelpar,” Boyer said, but noted that the final results from both trials to be published in the New England Journal of Medicine will offer greater insight into the clinical significance of the study findings.
References
- Bowlus CL, et al. Efficacy and safety of elafibranor in primary biliary cholangitis: Results from the ELATIVE double-blind, randomized, placebo-controlled phase 3 trial. Presented at: The Liver Meeting; Nov. 10-14, 2023; Boston (hybrid meeting).
- Hirschfield GM, et al. Efficacy and safety of seladelpar in patients with primary biliary cholangitis in the RESPONSE trial: A Phase 3 international, randomized, Placebo-controlled study. Presented at: The Liver Meeting; Nov. 10-14, 2023; Boston (hybrid meeting).
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