This episode follows S2 E43 in discussing the possible role of NASH cirrhosis clinical trials in the transition from biopsy as gold standard to a post-biopsy world. Stephen Harrison starts this conversation by reviewing a post hoc analysis of Phase 2 belapectin data from Galectin Therapeutics, followed by a review of the FALCON 2 stud of pegbelfermin in NASH cirrhosis, sponsored by Bristol Myers Squibb. Jörn Schattenberg, Mazen Noureddin and Roger Green add their perspectives to the conversation.
Stephen’s primary point from the belapectin post hoc analysis is a practical one: the high correlation between an AST:ALT ratio>1 and HVPG levels can help clinicians suspect which patients have cirrhosis and possibly define candidates for NASH cirrhosis clinical trials. Mazen states that given the lack of trial data in this area, any secondary data that can be interpreted or integrated into a broader analysis is exceptionally helpful. Stephen asks what the ideal design would be for a NASH cirrhosis trial starting today. While answers vary, they all rely heavily on non-invasive tests to provide richness to the data and possibly set a foundation to become primary endpoints over time. This leads Roger to observe how much more complex and disease-focused trial design discussions have become over just the past two or three years.