Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Summary

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Timeline

Start

2016-11-28

Primary completion

2018-09-07

Completion

2019-07-08

Outcome

Met primary endpoint

registry analysis (other test); MBX-8025 (2 mg) vs MBX-8025 (10 mg); p = 0.0021; ANCOVA NCT02955602 ↗

registry analysis (other test); MBX-8025 (5 mg) vs MBX-8025 (10 mg); p = 0.0024; ANCOVA NCT02955602 ↗

Publications

• Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dorffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA. A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. J Hepatol. 2022 Aug;77(2):353-364. doi: 10.1016/j.jhep.2022.02.033. Epub 2022 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seladelpar	Small molecule	2 mg	—
Subject	Seladelpar	Small molecule	5 mg	—
Subject	Seladelpar	Small molecule	10 mg	—

Indications