Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis
As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trial
A supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023
Excerpt from the Press Release:
CONSHOHOCKEN, Pa., Jan. 06, 2023 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced additional results from the pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah.
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. New data to be presented at NASH-TAG using a supportive analysis, a “consensus read” by the central pathologists of digitized biopsy images, supplement the positive topline findings and reinforce the strength of results observed in the primary analysis.
Stephen Harrison, M.D., Chairman for both Pinnacle Clinical Research and Summit Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University, and lead Principal Investigator of the MAESTRO studies, commented, “The magnitude and significance of effect observed for both of the dual primary endpoints was almost identical in the primary analysis and supportive consensus read analysis; this finding reinforces the resmetirom efficacy results. In addition, it is greatly encouraging to see the report of consistent treatment effects across a range of histological measures, including reduction by resmetirom of all components of the NAFLD Activity Score, steatosis, inflammation and ballooning, that measure the severity of NASH. The data demonstrate resmetirom’s potential impact on both the underlying steatohepatitis driving the disease and the fibrosis that is strongly associated with progression to negative clinical outcomes.”
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