Surfing the MASH Tsunami
Driving the Discussion in Fatty Liver Disease. Join hepatology researcher and Key Opinion Leader Jörn Schattenberg, Liver Wellness Advocate Louise Campbell, and Forecasting and Pricing Guru Roger Green and a global group of Key Opinion Leaders and patient advocates as they discuss key issues in Fatty Liver disease, including epidemiology, drug development, clinical pathways, non-invasive testing, health economics and regulatory issues, from their own unique perspectives on the Surfing the MASH Tsunami podcast. #MASH #MAFLD #FattyLiver #livertwitter #AASLD #GlobalLiver #NoNASH #EASL
Surfing the MASH Tsunami
S5 - E26.3 - Looking Back at #TLM2024 - FGF-21 Agents and the FDA Corner
In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation reviews the late-breaker presentation on efimosermin, a q4w FGF-21 agent and the "FDA Corner" session.
Jörn begins the discussion by highlighting a paper from the later breaker session on efimosfermin alfa, an FGF-21 agent dosed q4w. He notes that after only six doses (24 weeks), efimosfermin alfa demonstrated significant increases in fibrosis regression and lowering NAS score. To Jörn, this result, coupled with others on efruxifermin and pegozafermin, suggest that FGF-21s are likely to play a significant role in MASH therapy once approved. After Roger and Mike note their enthusiasm about the drug class and this study, Jörn mentions a study with 96-week efruxifermin that data demonstrates prolonged efficacy. As he points out, this matters because while studies of an earlier FGF-21 candidate suggested that antibodies might develop in FGF-21 therapy, that does not appear to be an issue here.
Mike asks the group why they feel placebo performs so well in clinical trials. Jörn suggests that working with a compassionate clinical care team in dealing with the patient leads to better performance on diet and exercise and, as a result, increased placebo response to what we might find in general community practice.
Michelle praises the FDA Corner session, particularly the agency's transparency and willingness to engage industry and academia in finding paths to move away from biopsy. She also notes some of the practical challenges inherent of moving away from biopsy using data from earlier trials with an outmoded histology reader setup. She is optimistic about the scientific community coming together to address these issues. Jeff praises the agency for an "amazing" session.