Nonalcoholic Steatohepatitis (NASH): Update Bulletin
This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in NASH market, including; Intercept Pharmaceuticals announcing the initiation of the global Phase III REVERSE study to evaluate the efficacy and safety of obeticholic acid (OCA; Ocaliva); Madrigal Pharmaceuticals reports positive top-line data from a Phase II clinical trial assessing MGL-3196 and GENFIT announcing the launch of the first clinical study in paediatric NASH patients to evaluate safety and efficacy of its dual PPARα/δ agonist elafibranor.
Business Questions:
Business Questions:
- What are KOL’s current views on obeticholic acid (OCA; Ocaliva) and what would they like to see from longer-term data?
- How do KOLs view the studies in the cirrhotic NASH patients given safety concerns with Ocaliva in PBC setting?
- Do KOLs think OCA can meet its primary endpoint in the REVERSE study?
- How do KOLs think OCA, if approved for NASH, is likely to be priced?
- How do KOLs rate the potential of Madrigal’s MGL-3196?
- Where is MGL-3196 best likely to fit into the treatment strategy? What do KOLs say?
- How do KOLs arte the development of elafibranor in paediatric NASH?
- What concerns do experts have with elafibranor in children?
- What are KOLs expecting from the Phase III RESOLVE-IT study for elafibranor?
