Nonalcoholic Steatohepatitis (NASH): Update Bulletin

  • ID: 4521397
  • Newsletter
  • FirstWord Publishing
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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 PPARa/d agonist elafibranor.

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?
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