Evaluating the safety and efficacy of seladelpar for adults with primary biliary cholangitis

Document Type

Article

Publication Date

8-1-2024

Publication Title

Expert opinion on pharmacotherapy

Abstract

INTRODUCTION: Seladelpar (MBX-8025) is a once-daily administered highly specific PPAR-δ agonist in Phase 3 and extension trials for use in patients with primary biliary cholangitis (PBC).

AREAS COVERED: This review provides background on current treatment options for PBC, and summarizes clinical trial data regarding the safety and effectiveness of seladelpar within the context of these treatments.

EXPERT OPINION: Clinical trials results demonstrate the safety and tolerability of seladelpar use for PBC, including in patients with cirrhosis. The primary composite endpoint (ALP <1.67 times ULN, decrease ≥ 15% from baseline, and TB ≤ULN) was met in 61.7% of the patients treated with seladelpar and in 20% receiving placebo (p < 0.001). Moreover, pruritus - a cardinal and often intractable symptom of PBC - was improved with seladelpar treatment, as were overall quality of life measurements. Improvements in markers of inflammation were likewise observed. These biochemical and clinical findings therefore represent landmark developments in PBC treatment and offer a therapeutic option for PBC.

Medical Subject Headings

Humans; Liver Cirrhosis, Biliary; Quality of Life; Adult; PPAR delta; Pruritus; Propionates; Chalcones

PubMed ID

39107982

Volume

25

Issue

11

First Page

1517

Last Page

1523

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