What Sets Seladelpar Apart From Other PBC Therapies

While the primary biliary cholangitis (PBC) treatment landscape has long been limited to just a handful of agents with limited efficacy, 2024 saw a major shift in PBC management with the addition of 2 new second-line therapies.

Seladelpar (Livdelzi), a proliferator-activated receptor (PPAR) delta agonist, was one of these recent additions to the PBC treatment armamentarium and was a major topic of discussion at The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD) in San Diego, California.

Findings from a 2.5-year interim analysis of the ongoing open-label phase 3 ASSURE study were presented in a late-breaking abstract at the meeting and highlight seladelpar’s sustained efficacy and long-term safety for the treatment of PBC.

In this segment, which is part 3 of a 4-part series, experts Palak Trivedi, MD, PhD, and Eric Lawitz, MD, discuss what sets seladelpar apart in the evolving landscape of PBC therapies.

Trivedi emphasizes seladelpar’s unique design as a PPAR delta agonist, citing clinical trial data that demonstrated its significant impact on both liver biochemistry and patient symptoms, particularly pruritus. He notes the importance of this data in guiding treatment choices, especially in the absence of head-to-head comparisons with other recently introduced agents and as clinicians start to face critical questions on sequencing and tailoring therapies to individual patient needs.

Lawitz adds that seladelpar’s combination of efficacy and tolerability distinguishes it from other second-line treatments. He says its unique ability to alleviate pruritus, a symptom notoriously difficult to manage in this patient population, not only enhances quality of life but also addresses a key gap in patient-centered care.

Experts:

Palak Trivedi, MD, PhD: associate professor and honorary consultant hepatologist and clinical research director for industry engagement at the University of Birmingham

Eric Lawitz, MD: medical director of the Texas Liver Institute and a clinical professor of medicine at the University of Texas Health San Antonio

Relevant disclosures for Trivedi include Bristol Myers Squibb, Gilead, Intercept, CymbaBay, and others. Relevant disclosures for Lawitz include 89Bio, Boehringer Ingelheim, Merck, Novo Nordisk, Sagimet Biosciences, AstraZeneca, Bristol Myers-Squibb, Cymabay, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Intercept, Ipsen, Madrigal, Novartis, Regeneron, Takeda, Terns, Viking Therapeutics, AbbVie, and others.

References

1. Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed December 4, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis
2. Brooks A. Seladelpar (Livdelzi) Demonstrates Long-Term Benefit for Primary Biliary Cholangitis. HCpLive. November 15, 2024. Accessed December 4, 2024. https://www.hcplive.com/view/seladelpar-livdelzi-demonstrates-long-term-benefit-primary-biliary-cholangitis