Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Primary:

To evaluate the long-term safety and tolerability of seladelpar

Secondary:

To evaluate the long-term efficacy of seladelpar

Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations
required by local law

2. Participated in a PBC study with seladelpar

3. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose

Exclusion Criteria:

Exclusion criteria are applicable only for subjects with study drug interruption greater
than four weeks prior to Day 1 of this study.

1. Treatment-related adverse event leading to study drug discontinuation in a previous
PBC study with seladelpar (MBX-8025)

2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)

3. AST or ALT above 3 × ULN

4. Total bilirubin above 2.0 mg/dL

5. Creatine kinase above 2.5 × ULN

6. Serum creatinine above 1.5 × ULN

7. Auto-immune hepatitis

8. Primary sclerosing cholangitis

9. Known history of alpha-1-antitrypsin deficiency

10. Known history of chronic viral hepatitis

11. For females, pregnancy or breast-feeding

12. Use of colchicine, methotrexate, azathioprine, or systemic steroids within two months
prior to screening

13. Current use of fibrates or simvastatin

14. Current use of obeticholic acid

15. Use of an experimental or unapproved treatment for PBC

16. Use of experimental or unapproved immunosuppressant

17. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the Investigator