belapectin

The 5th Global NASH Congress will take place in London (in person only) on May 27 and 28. Louise Campbell and scientist/entrepreneur Rachel Zayas, who will cover the Congress for NASH Tsunami, join Ian Rowe and regulars Jörn Schattenberg and Roger Green to discuss some key papers and issues covered there. This conversation starts with Ian Rowe and Jörn Schattenberg sharing their perspectives on how much of the emerging genetics and omics of Fatty Liver disease clinicians need to understand. This transitions into a discussion of the drug development presentations in the meeting and what we stand to learn from these.

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. Terns Pharma CEO Sen Sundaram joins this conversation from the audience to ask whether the term "cirrhosis" is medically helpful or might warrant replacement with "end stage liver disease." After vigorous discussion on this point, Sen departs and Stephen Harrison leads the group through a review of four ongoing NASH cirrhosis trials. The discussion veers into the issue of which analytics methods designers are specifying and why. At one point, Naim Alkhouri, frequent guest and principal investigator on the Gilead combination agent trial before the session ends. His specific contribution: MRE was not included in the Gilead trial largely for cost reasons.

The most striking fact to emerge from this conversation relates to the "beyond the biopsy" question. MRE is emerging as a highly reliable NIT that appears to produce reliable results regardless of mode of action and is generating correlations and ratios to fibrosis level decreases and other key metrics, yet it is not included in the designs of any ongoing NASH cirrhosis trial. Stephen describes this as the "stovepiping" of data. Companies consider the data they need, not ways it can be aggregated with other trials to solve larger issues. This issue bears further exploration in later episodes.

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.

Naim Alkhouri, Ian Rowe and GenFit Global Diagnostics Leader Suneil Hosmane join Louise Campbell and Roger Green to review presentations from Day Two at the 4th Global NASH Congress.

On April 29, over 175 NASH stakeholders from across the globe met virtually to hear 20 presentations from leaders in academia and industry. SurfingNASH selected 9 presentations to discuss in a session recorded right after the conference concluded. When  the five panelists got together, the discussion extended to 90 minutes...too long for a single episode.

Episode 22 features Naim Alkhouri and Louise Campbell discussing featured presentations on genomics, transcriptomics and the genetics of precision medicine, plus a review of belapectin and non-hepatologist awareness of and commitment to treat NASH and NAFLD.  The conversation features deep dives into drug development and debates on the proper public health strategy for treating NAFLD patients. Stimulating...engaging..."can't miss."

HEP Dynamics will publish the rest of the Day Two reviews in Episode 23 on Saturday, May 1.