Takeaways From Our Well-Attended NYC Omakase Dinner

研报英文原文证据摘录

Takeaways From Our Well-Attended NYC Omakase Dinner

C O M PA N Y N O T E

J u n e 2 3 , 2 0 2 6

4. Importantly, MDGL was thoughtful about patient selection in MAESTRO-NASH-OUTCOMES

to ensure they enrolled a high risk F4 population and a sufficient amount of events would accrue

to efficiently conduct the trial (note here). For reference, a substantial portion of patients had

clinically significant portal hypertension which is a key risk factor for liver-related outcomes

events. Accordingly, mgmt reminded us the journey to decompensation in a patient who recently

switch from F3 to F4 can take a long time, so the purpose of recruiting a high-risk F4 population

was to ensure enough events accrued over time. See pgs. 4-5

5. Notably, the PoS for MAESTRO-NASH-OUTCOMES is supported by data from Ph3

MAESTRO-NAFLD OLE (NCT04951219) cirrhosis cohort data which showed that patients

demonstrated a 6.4 kPa reduction in VCTE after 1-year and a 6.7 kPa reduction in VCTE after

2-years (note here). Specifically, the reduction of >5 kPa observed in MAESTRO-NAFLD OLE

supports that the patients were on average moving into a lower risk category with reduced

risk of poor liver outcomes. Additionally, the patients in the cirrhosis cohort also experienced

improvements in other key endpoints such as MRE, liver function tests (LFTs), and other

biomarkers. See pgs. 5-6

6. With this, MDGL does not plan to do interim or futility analyses for Ph3 MAESTRO-NASH-

OUTCOMES. See pg. 6

7. Accordingly, if MAESTRO-NASH-OUTCOMES is positive it would effectively support full

approval of REZDIFFRA in F2, F3, and F4 MASH given it would show that REZDIFFRA is able to

reduce disease progression (where the unmet need in MASH is based on preventing progression

rather than a reduction in fibrosis).