CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has announced positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial, demonstrating the potential of Rezdiffra (resmetirom) to significantly reduce liver stiffness in patients with compensated MASH cirrhosis (F4c), a critical marker for liver disease progression.
Patients in the open-label arm of the study achieved an average 6.7 kPa reduction in liver stiffness, as measured by vibration-controlled transient elastography (VCTE). This reduction represents the largest improvement reported in this patient population to date. Furthermore, 51% of participants achieved at least a 25% reduction in liver stiffness, an improvement associated with lower risks of advancing to end-stage liver disease.
“These data demonstrating patients with compensated MASH cirrhosis achieved marked reductions in VCTE are highly encouraging,” said Mazen Noureddin, M.D., M.H.Sc., a leading liver disease expert. “A mean 6.7 kPa reduction suggests many patients are moving into lower risk categories for liver-related events.”
Rezdiffra exhibited a safety profile consistent with previous clinical trials, with low discontinuation rates due to adverse events. Becky Taub, M.D., Chief Medical Officer and President of Research & Development at Madrigal, emphasized the urgency of addressing MASH cirrhosis, noting, “Patients with MASH who progress to cirrhosis face a 42-times higher risk of liver-related mortality. These new data reinforce our confidence in the ongoing MAESTRO-NASH OUTCOMES trial, which could position Rezdiffra as the first approved therapy for F2-F4c MASH.”
The ongoing MAESTRO-NASH OUTCOMES trial is evaluating the progression to liver complications in patients treated with Rezdiffra compared to a placebo. A positive outcome could pave the way for full approval and establish Rezdiffra as a groundbreaking option for treating this underserved patient population.
Madrigal plans to present additional findings from the MAESTRO-NAFLD-1 trial at an upcoming medical conference, continuing its commitment to advancing care for MASH patients.
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