Insights from Long-Term ASSURE Data for Seladelpar

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 the final installment of a 4-part series, experts Palak Trivedi, MD, PhD, and Eric Lawitz, MD, discuss the long-term ASSURE data and what they add to our understanding of seladelpar’s safety and efficacy for PBC.

Trivedi begins by emphasizing the significance of seladelpar’s long-term safety profile, calling attention to the lack of new treatment-emergent adverse events or concerning safety signals. While acknowledging the inherent limitations of safety extension studies without matched control groups, he describes how the ASSURE data provide confidence in the drug’s sustained biochemical response and tolerability, additionally advocating for real-world studies to validate these findings and establish whether seladelpar improves transplant-free survival over time beyond its biochemical markers.

Similar to Trivedi, Lawitz highlights the importance of long-term follow-up in chronic therapies. He notes that the ASSURE data not only confirm the stability of seladelpar’s safety profile but also reveal a potential increase in efficacy with extended treatment. He notes the consistent durability and lack of unexpected toxicities offer clinicians greater confidence in prescribing seladelpar for prolonged use.

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