Nonalcoholic Steatohepatitis (NASH): Update Bulletin

Nonalcoholic Steatohepatitis (NASH): Update Bulletin

Introduction

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:

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?