S4-3.4 – NASH-TAG Review: Insights on the F3 Population and AI-Assistance for Improving Therapeutic Efficacy

S4-3.4 - NASH-TAG Review: Insights on the F3 Population and AI-Assistance for Improving Therapeutic Efficacy
Surfing NASH highlights key moments from its coverage of a historic NASH-TAG conference. In this conversation, Naim Alkhouri, Amy Articolo, Jörn Schattenberg and Roger Green explore key takeaways, insights on the F3 population and using AI-assisted assessment to improve those therapeutic efficacy.

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend’s conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.

This conversation with Naim Alkhouri, Amy Articolo and Jörn Schattenberg begins with Naim illustrating some of the high points of the meeting.

First, he recaps the resmetirom data. He then highlights that Intercept’s study of patient response to obeticholic acid (OCA) revealed improvements among the F3 population. He concludes that in the wake of these aforementioned results, there remains plenty of opportunity to improve and other biotechs “are still in the game” with the energy to back them. Jörn notes the high level of engagement from academia in supporting development through the consortia, NIMBLE and LITMUS. Amy credits the collaborative spirit of the meeting and the milestones achieved in improving the field’s understanding of how best to utilize NITs to provide insight and serve patient needs.

Roger Green steers conversation toward the challenges of payers and gaps in therapeutic efficacy for certain populations. He connects these ideas to slides presented by Naim on AI-driven zonal analysis developed by HistoIndex. The assessment provides a geographic vantage point that offers perspective on how to combine agent benefits and trial emerging opportunities. Amy agrees that some of the complex analytics will help pharma build its case for patients. Naim questions what we call “futility” – if patients stay the same, are they futile? He suggests that AI can help us determine whether people who do not reduce fibrosis are actually benefiting from therapy. Roger notes that Naim outlined three categories: patients whose fibrosis regressed, others who progressed and a third group somewhere in the middle yet to be defined. Naim agrees and underscores that with the non-invasive tests available, we can learn far more than what’s known today. Amy responds with questions around how tests will be used practically, noting that stacked tests are pivotal to the story. As the conversation ends, Jörn notes biopsy is only one way to generate a conditional endpoint for drug approvals.

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