Surfing the MASH Tsunami

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In a riveting debut of Season 4 on Surfing the NASH Tsunami, the podcast offers real time coverage of the highly anticipated NASH-TAG 2023. This episode includes two recordings. In the first conversation, NASH-TAG 2023 co-course director Stephen Harrison, scientific advisory board committee member Jörn Schattenberg and fellow Key Opinion Leader Mazen Noureddin join Roger Green to review presentations and themes from the Friday afternoon session. This conversation centers largely around Friday afternoon’s presentation on NITs. The group focuses on the expansion in NIT knowledge in terms of the number of NITs available, the breadth of knowledge they cover and the ways NITs can be used to manage patients wisely today. The conversation also focuses on the features that make NASH-TAG such a unique meeting.

In the second conversation, Fatty Liver Alliance Founder Michael Betel and NASH kNOWledge Founder Tony Villiotti join Roger and Louise Campbell. This discussion highlights how the momentum of recent pivotal trials in NASH drug development is changing patient advocacy today. The main insight: as more information becomes available and as we see successful Phase 3 drug trials, the number of stakeholders needing information increases and what each group needs to know varies. All this portends an exciting future for patients and their caregivers.

To discover the energy for yourself, surf on to the episode and stay tuned with our continued coverage. 

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this final segment, Ian Rowe joins Jörn and Roger to share his  takeaways.  

Ian begins this conversation by discussing his impressions on Madrigal’s announcement of positive topline results from the Phase 3 MAESTRO-NASH trial of resmetirom. He describes the event as a milestone in the development of NASH therapies that illuminates the need to prepare for how to most meaningfully make future treatments accessible to patients. This segues into regulatory frameworks and process of approval through NICE in the UK. From here, Roger steers conversation to consider efforts in the UK to expand Fatty Liver screening into primary care. Ian goes on to discuss at depth the pivotal role NITs will come to play in patient management.

Looking toward the future and excitement around drugs coming to market, Ian describes two tangible ways he envisions a shift in his practice. First, he highlights the importance of driving disease awareness and education around prognosis. Second, he hopes energies and insights will increase interest and focus into the alcohol-related liver disease which dominates his inpatient practice. The group continues on to compare and contrast ideas around a shared pathway, stigmas and other nuances around alcoholic versus nonalcoholic liver diseases. As the conversation wraps up, Ian shares what he hopes for and expects in 2023. 

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this exclusive segment, podcast co-founder and former co-host, Stephen Harrison, joins Louise and Roger to discuss the year-in-review as recorded before Madrigal’s breaking announcement of the Phase 3 MAESTRO-NASH results last week.

From the outset, Stephen admits there were “a lot of pleasant surprises” this year, alluding to the multiple positive Phase 2 trial results among other recent press releases. He anticipates several exciting modes of action becoming available in the imminent future. The interview goes on to look at advancements made in methodology of interpreting liver biopsies, understanding the limitations of biopsy and degrees of mitigation in response to those shortcomings. Stephen also offers in-depth investigation into the uptake of NITs as conditional clinical trial endpoints, something he sees as a process whose momentum keeps growing and strengthening.

Throughout this session, Stephen provides speculation as to what the promising new year holds for the Fatty Liver field. In his words, 2022 revealed “the most incremental advances in the field of NASH in the past decade.” He adds that, like this year, 2023 is primed to be pivotal. Surf on for the full-length, insight-laden interview with a remarkable physician and Principal Investigator making tremendous contributions to the pursuit of putting a major dent in Fatty Liver. 

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this exclusive segment, Naim Alkhouri joins Louise and Roger to discuss drugs, NITs, digital diagnostics and the importance of preventing pediatric and adolescent NAFLD.

Naim begins by highlighting the FDA approval of the ELF test, which has assisted him in the risk stratification of patients who fall in the indeterminant zone. He then underscores an impressive spate of positive moments from the year, touching on AASLD presentations and guidance documents, and clinical trial results and the implications for NASH therapeutics. After expanding on developments in digital diagnostics, Naim points to how this improves screening for the diabetic population and ultimately can further prevent disease progression. Louise prompts comments around the availability and efficacy of FIB-4. Naim suggests that outside of special patient populations at elevated risk for liver disease, FIB-4 poses limitations to be addressed. The conversation continues on the subjects of lifestyle interventions and the alarming prevalence of NAFLD in younger populations. Naim points out that with 15% of children and 25% of adolescents and young adults having NAFLD, treating fatty liver is a preventative measure against diabetes. He states he would like to design and execute a clinical trial that further investigates this relationship.

The group next explores the idea of preventative hepatology and the bigger picture role of primary care in combating NAFLD.  As the conversation winds down, they discuss elements of emerging drug developments and closing thoughts on the momentous year. Surf on for more takeaways from what is an infectiously optimistic and compelling interview. As he usually does, Naim covers a tremendous amount of intellectual territory clearly and concisely in not that much time.

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The latter half of December marks the Surfing the NASH Tsunami annual NAFLD Year-in-Review. In Part 3 of this Season 3 finale, Surfers Jörn Schattenberg, Louise Campbell and Roger Green interview Naim Alkhouri, Stephen Harrison and Ian Rowe to discuss putting a dent in Fatty Liver disease in 2022 and beyond. This final episode of the year features compiled excerpts from our respective guest interviews. Each interview in its entirety will debut as independent segments released over the weekend.

Surf on to hear the diverse and powerful perspectives provided by a handful of the field’s Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022.

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this exclusive segment, Jeff Lazarus opens in full disclosure admitting that, overall, 2022 has been a tough year in health care as “everyone is overwhelmed” while we all try to emerge from the pandemic. Regarding the status of Fatty Disease, Jeff is more optimistic as this year witnessed movement outside of hepatology into the space of diabetes societies and primary care meetings. Such collaborative energy is needed “to understand the metabolic syndrome and not just silos.” Jeff goes on to cite a return to an in-person Wilton Park meeting as an example turning point for such synergies.

The conversation evolves to consider targets, goals, endpoints and some small distinctions between each in the framework of public health. Jeff notes that we will need what he describes as a “drugs-plus approach” to address Fatty Liver disease - similar to that vaccines were not the single defense in combating the COVID pandemic. While drug therapies may be the cornerstone for fatty liver disease, there remains the need for lifestyle interventions through diet and exercise. As Jeff indicates, this mission is larger than hepatology alone. While a wider net of stakeholders establish clinical care guidelines in the context of professional societies, there still lacks, in example, a technical strategy coming from an organization such as the W.H.O. Jeff believes establishing work around the Sustainable Development Goals is important in showing the connection between different targets and the liver. He extends this idea to connect socioeconomic variables to liver health outcomes.

The group also explores the idea that when drugs become available to market, treater interest picks up because there is encouragement from the fact that something that can be done. Jeff hopes this positive energy will also recruit more resources in the form of nutritionists and dieticians. He raises questions around imagining what new models of care look like, and how do we improve communications and teamwork. His response: the availability of drugs and the imminent availability of drugs will set fire to the changes that will need to follow. He adds comments on the importance of addressing the policy arena and ensuring policymakers and health authorities are aware of the potentially deadly, highly prevalent condition. They need to be aware that there are soon to be approved and available drugs, and that the majority of this population is undiagnosed. Jeff further reasons that Fatty Liver is in need of a more proactive approach that identifies and educates on the risks of disease progression before advanced fibrosis takes hold. As the conversation winds down, the group investigates the implications and process behind ongoing discussion on nomenclature.

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this exclusive segment, Ken Cusi expands on “the year it all came together.”

Ken opens by stating that 2022 has been a momentous year for fighting Fatty Liver as a result of decades of work from a myriad of groups and contributors. He specifically points to the critical efforts of developing guidelines in preparing the field for a drug approval - especially as Phase 3 trials suggest new NASH therapies are on a shorter-term horizon. The culmination of these guidelines and progression toward earlier screening primes 2023 to be yet another historic year. All of which underscores the importance of driving education and increasing awareness of liver health. It's suggested that 2022 has been the year in which the field expanded beyond the interest of hepatologists alone and adopted the attention and collaborative energy of a wider net of stakeholders, including endocrinologists and primary care professionals. From here Ken expands on a brief roadmap as to how we arrived at these points of convergence.

The conversation continues with comments on the versatility of the FIB-4 test. The group revisits a common topic on this podcast whereby different systems from around the world are compared and contrasted in terms of their capacities to utilize FIB-4 and other liver health data in an electronic medical record. Ken reiterates the importance of patient education going forward as he believes patients have an active role to play in the collective goal of putting a dent in Fatty Liver disease. As the conversation winds down, he addresses a number of other subjects including thoughts on nomenclature, different approaches to weight-loss therapies, and the role of policymakers in promoting liver health. 

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In the Season 3 NAFLD Year-in-Review conversations series, Surfers Jörn Schattenberg, Louise Campbell and Roger Green embark on a string of interviews with a handful of Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022. In this exclusive segment, Mazen Noureddin reflects on both personal and professional developments. 

Mazen begins by describing a move from Los Angeles to Houston where he is focused on establishing the state-of-the-art Houston Research Institute. He next highlights contributing to the development of a highly specific MRI-based (MAST) score to identify patients with fibrotic NASH as a major achievement of the year. In another underscore, Mazen points to presenting an abstract at AASLD last month on top-line results from a phase 2a trial on the mitochondrial uncoupler, HU6. Jörn joins to prod into the latter presentation and ask whether mechanisms trialed in obesity and other metabolic diseases are trending toward being investigated within hepatology. Mazen suggests that while mitochondrial uncouplers have been explored for many years, recent innovation in NASH can be an expected path given the nature of being a multi-systemic disease. He goes on to describe determining nuances in the efficacy of weight-loss medications and their different mechanisms of action.

From here the conversation picks up on the increasing optimism around the use of NITs and Mazen’s involvement  with the NAIL-NIT Consortium. Roger notes that earlier in the year, Mazen stood out as someone who aggressively pushed a closing window toward moving beyond the biopsy. Remarkably, Mazen’s optimism and confidence in the development and implementation of NITs still projects these faster advancements. As the session winds down, Mazen speaks to what he hopes to see in the coming year. 

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The latter half of December marks the Surfing the NASH Tsunami annual NAFLD Year-in-Review. In Part 2 of this Season 3 finale, Surfers Jörn Schattenberg, Louise Campbell and Roger Green interview Mazen Noureddin, Ken Cusi and Jeff Lazarus to discuss putting a dent in Fatty Liver disease in 2022 and beyond. This episode features compiled excerpts from our respective guest interviews. Each interview in its entirety will debut as independent segments released throughout the week.

Surf on to hear the diverse and powerful perspectives provided by a handful of the field’s Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022.

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In a monumental moment in the never-ending pursuit of putting a major dent in Fatty Liver disease, Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH clinical trial of resmetirom for the treatment of NASH and liver fibrosis. Madrigal’s leadership intends to file for resmetirom’s accelerated approval with the FDA in the first half of 2023. If approved, the drug may become the first NASH medication introduced to market, depending on the outcome and timing of Intercept Pharmaceuticals’ refiling of obeticholic acid.

To recognize this special occasion, Surfing the NASH Tsunami hosts its largest ever suite of panelists who react to the enthusiasm, synergy and implications surrounding the news. This final conversation starts with Roger Green following up on a couple of earlier comments. First, he notes the fact that in other diseases, a combination therapy can get approved before each element of monotherapy has been approved. Second, he notes that semaglutide’s Phase 2 result, with 72-week effects on steatosis and NAS activity score but not fibrosis regression, aligns with Scott Friedman’s earlier statement that not all fat lowering may mean the same thing in the liver. Jörn Schattenberg and Mazen Noureddin follow-up with other comments about NAS, fibrosis and lipotoxicity. This leads Jörn to note that there is already a second THR-beta in trial, from Viking Therapeutics, and asks what this trial might mean for Viking. Mazen cites Terns as another company with other drugs, including a THR-beta in the pipeline, and believes they will benefit as well. Scott asks what all this means for patients with cirrhosis. Rachel Zayas then discusses some of the development work her company is doing and how these results might affect her work and ability to raise resources. As the session winds down, Kris Kowdley describes one more way that the use of companion diagnostics against dose response and non-response will aid payers. For her final thoughts, Louise Campbell discusses how we might consider this a major anti-cancer advance given how the liver is implicated not only in HCC but also in non-hepatic cancers. Surf on to hear the diverse array of closing takeaways from the rest of the group.