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Madrigal Pharmaceuticals Presents Phase 3 MAESTRO-NASH Data During the Opening General Session of the EASL Congress™

Published: 2023-06-22 07:30:00 ET
<<<  go to MDGL company page
  • First scientific presentation of detailed MAESTRO-NASH results confirms achievement of primary endpoints across multiple patient subgroups
  • Noninvasive imaging and biomarker data support findings on liver biopsy and demonstrate broad treatment response to resmetirom
  • Further analyses of results reinforce resmetirom safety and tolerability profile
  • Company to host an investor event and webcast on Saturday, June 24 at 6:30 PM CEST / 12:30 PM ET

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-valueResmetirom100 mg(n=321)p-valuePlacebo(n=318)
NASH resolution (ballooning 0, inflammation 0,1) with ≥2-point reduction in NAS and no worsening of fibrosis26%