Emma Gutstein

Emma Gutstein asked how Rezdiffra's strong uptake and adherence rates inform Madrigal's view of the drug's chronic use potential and steady-state demand over the long term.

Answer

CEO Bill Sibold emphasized Rezdiffra's 'holy grail profile' (once-daily, well-tolerated pill) makes it well-positioned for long-term chronic therapy, contrasting it with initial products in other chronic disease categories. CMO David Soergel added that sustained efficacy, as shown in AASLD data (including reversion upon treatment interruption), further supports its chronic use potential.

Emma Gutstein asked how Rezdiffra's strong uptake and reported 60-70% adherence rate inform Madrigal's view of the drug's chronic use potential and steady-state demand over the long term.

Answer

Bill Sibold, Chief Executive Officer, highlighted Rezdiffra's 'holy grail profile' as a once-daily, well-tolerated pill, positioning it strongly for long-term chronic therapy, unlike initial launches in other chronic disease categories. David Soergel, Chief Medical Officer, added that sustained efficacy, as demonstrated by AASLD data and the observed disease reversion upon treatment interruption, combined with sustained tolerability, are crucial for chronic use.

Emma Gutstein, on for Andy Chen, asked about other key findings to anticipate from the upcoming EASL presentations, aside from the main F4c late-breaker data.

Answer

CEO William Sibold emphasized that the F4c late-breaker is the most significant presentation. He noted that other abstracts will cover a broad range of topics, including the unmet need in MASH, real-world data from German claims analysis, and disease severity. He highlighted the meeting as a key opportunity for dialogue with the global physician community.

Emma Gutstein, on for Andy, inquired about Roivant's strategy for navigating the increasingly competitive dermatomyositis (DM) market. She also asked about specific preparations and key milestones for a potential commercial launch in DM over the next 6-12 months.

Answer

CEO Matt Gline emphasized that being first to market is a key advantage. He highlighted brepocitinib's potential for strong clinical benefit, its oral formulation, and the company's strong, established reputation with the physician community. Regarding launch preparations, Gline noted that while major activities await Phase 3 data, the team is actively engaging with physicians, which he identified as a critical component of a successful biotech launch.

Emma Gutstein asked about Roivant's expectations for the upcoming brepocitinib Phase III readout in dermatomyositis and the potential competitive landscape, considering Argenx's entry.

Answer

CEO Matthew Gline expressed excitement, noting that if successful, brepocitinib would be a first-in-class new mechanism in DM, years ahead of any known competitor. He highlighted the oral form factor as a key differentiator and stated there is ample unmet need for multiple new therapies. Gline also suggested that the dual TYK2/JAK1 inhibition has the potential to be a best-in-class mechanism for inflammatory diseases, though this will take years to prove.