S5 - E12.6 - From The Vault: More Different Roles For NITs In MASH
Send us a text One theme in this week's episode involves different ways to use NITs in drug development and assessing the value of older drugs in MASH. This conversation, from our review of last September's FDA workshop on NITs, considers two additional roles that NITs might play in drug development. The conversation includes Jörn Schattenberg, Louise Campbell, Roger Green, and guest Laurent Castera. The original post has an excellent description: This conversation begins with a discussion...
28 Apr 202412min
S5 - E12.5 - MASH Drug Development: Combining With Old Drugs And Shortening Time To Approval
Send us a text This wrap-up conversation about MASH Drug Development covers two issues: combination therapies with old drugs and using NITs to speed and smooth the path to approval. Louise Campbell starts this final conversation by asking whether we are paying sufficient attention to old drugs that might have value in MASH. She points to a recent study demonstrating that low-dose aspirin significantly affects liver fat and suggests that we are not thinking broadly enough about use of older a...
28 Apr 202411min
S5 - E12.4 - MASH Drug Development: Implications Of Concomitant Metabolic Therapy Use
Send us a text This conversation starts by focusing on the impact of concomitant metabolic therapies in MASH drug development and patient treatment and then moves on to explore some major implications of the earlier conversations. Roger Green begins this conversation by returning to the issue of metabolic drugs. Specifically, he mentions a recent tirzepatide Phase 3 trial that demonstrated efficacy against symptoms of obstructive sleep apnea. Louise Campbell points out that sleep apnea...
28 Apr 202413min
S5 - E15.3 - MASH Drug Development: Improvement Since 2020 And Issues That Remain
Send us a text This conversation includes two sections: one optimizing efficacy endpoints to reflect clinical practice and a second looking back at what has improved in MASH drug development since 2020. The first part of this discussion explores the idea that MASH drug development should reflect the clinical use of the target drug. Sven Francque starts by discussing how much larger the drug effect for Rezdiffra looks if we add lack of fibrosis progression to regression in creating the effica...
27 Apr 202411min
S5 - E12.2 - MASH Drug Development: Improving Efficacy Endpoints
Send us a text In this conversation, the panel discusses challenges in MASH Drug Development that are centered around efficacy endpoints and NAS scoring. This conversation starts with Will Alazawi suggesting that the MASH clinical trial field suffers from the previous experience with Hepatitis C, where medications became capable of eradicating disease in a fairly linear fashion. He suggests that MASH trials undervalue the value of simply preventing progression, which leads Sven Francque to n...
27 Apr 202412min
S5 - E12.1 - MASH Drug Development: The State Of The Graveyard 2023
Send us a text In this initial conversation, Sven Francque shares some of the key messages from the MASH Drug Development graveyard paper he co-authored in 2023. Jörn Schattenberg and Will Alazawi comment. This conversation explores key points from Learnings from the Graveyard of Phase 2 and 3 Nonalcoholic Steatohepatitis Trials, which Sven Francque co-authored in 2023 with Aleksander Krag and Mazen Noureddin on lessons from recent clinical trial failures and the reasons to be more hopeful ...
27 Apr 202411min
S5 - E12 - MASH Drug Development: What Failures Taught Us About Success
Send us a text In this conversation, Sven Francque and William Alazawi join Jörn Schattenberg, Louise Campbell, and Roger Green to review papers co-authored by Sven in 2023 and Jörn in 2020 to discuss what failure has taught us about future MASH drug development. 00:00:00 - Surf's Up: Season 5 Episode 12 Roger comments briefly on Stephen Harrison's passing and explains why this episode will be more sedate than usual. 00:01:45 - Introduction Opening comments from panelists. 00:02:28 - Groun...
25 Apr 202454min
S5 - E11.6 - From The Vault: Another Strategic Role For Prescribing MASH Drugs
Send us a text Earlier in this episode, the panel discusses different prescribing models for MASH drugs, triggered by Roger Green's question about whether MASH prescribing will resemble an oncology model. This conversation, from the EASL Congress 2023 wrap-up episodes, takes a very different view of the relationship between MASH and oncology. The conversation includes Jörn Schattenberg, Stephen Harrison and Roger Green. The original post has an excellent description: This conversation start...
21 Apr 202411min
