EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS PREVIOUSLY TREATED WITH FIBRATES OR OBETICHOLIC ACID
Recommended Citation
Villamil AM, Pratt D, Kremer AE, Calvaruso V, Dominguez EG, Missen L, Qi X, Proehl S, Barchuk WT, Watkins TR, Gordon SC. EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS PREVIOUSLY TREATED WITH FIBRATES OR OBETICHOLIC ACID. Gut 2025; 74:A32.
Document Type
Conference Proceeding
Publication Date
10-6-2025
Publication Title
Gut
Abstract
Seladelpar is a first-in-class delpar (selective PPAR-delta agonist) indicated in the UK for the treatment of primary biliary cholangitis including pruritus in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. RESPONSE was a Phase 3, randomised, placebo-controlled clinical trial of seladelpar in patients with inadequate response or intolerance to UDCA. Patients completing RESPONSE were eligible to roll over into ASSURE (NCT03301506), an ongoing, open-label, long-term, Phase 3 safety trial. Here, we describe data from month 18 (month 6 of ASSURE) in patients with or without prior use of fibrates or obeticholic acid (OCA) who rolled over from RESPONSE into ASSURE. Patients received 10 mg seladelpar orally daily or placebo in RESPONSE; patients received open-label 10 mg seladelpar in ASSURE. Fibrates and OCA were prohibited during the study period and a 6-week washout was required prior to entry in RESPONSE. Data were described for patients in ASSURE with or without prior use of fibrates OCA and based on whether they received seladelpar (continuous seladelpar patients) or placebo (crossover patients) in RESPONSE. Efficacy included the percentage of patients achieving a composite biochemical response (CBR; alkaline phosphatase [ALP] <1.67 × upper limit of normal [ULN], ALP decrease >15%, and total bilirubin
Volume
74
First Page
A32
