CONSHOHOCKEN, Pa., June 22, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today presents resmetirom Phase 3 MAESTRO-NASH data at the opening general session of the European Association for the Study of the Liver Congress (EASL 2023).
In December 2022, Madrigal announced that MAESTRO-NASH achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis including: 1- NASH resolution (ballooning 0, inflammation 0,1 with ≥2 point improvement in NAFLD activity score (NAS) and no worsening of fibrosis) 2- ≥1-stage reduction in fibrosis with no worsening of NAS.
Primary Endpoint (mITT*) | Resmetirom80 mg(n=316) | p-value | Resmetirom100 mg(n=321) | p-value | Placebo(n=318) |
NASH resolution (ballooning 0, inflammation 0,1) with ≥2-point reduction in NAS and no worsening of fibrosis | 26% |