January 22, 2021
Causality assessment for suspected drug-induced liver injury (DILI) is a major challenge during drug development and becomes a greater challenge when studies are done in patients with NASH who typically enter the trial already with liver blood test elevations. The role of a liver biopsy in the diagnosis and management of suspected DILI is a subject of ongoing debate.
The goal of Part 1 of Session 3, Lessons Learned from Seladelpar Phase 2b Study, was to address:
1. Lessons learned from drug development in liver disease.
2. Understanding the spectrum of histological findings that can be seen in NASH other than inflammation, ballooning, steatosis and fibrosis.
3. Understanding the presentation of interface hepatitis in NASH patients.
4. Best practices for assessment of unexpected or atypical findings found on histology.
Materials
Presentations
Lessons Learned from the Seladelpar Phase 2b Study
Melissa Palmer, Gannex Pharma (a wholly owned company of Ascletis Pharma)
NASH Histology Findings and Seladelpar Hepatotoxicity Review Committee (pending)
Charles McWherter, CymaBay
Lesions Atypical for NASH/NASH Resolution in EOT Biopsies
Elizabeth M Brunt, Washington University School of Medicine in St. Louis
Cynthia Guy, Duke University School of Medicine
