Madrigal Pharmaceuticals, Inc. (MDGL) announced encouraging two-year results from the open-label compensated MASH or metabolic dysfunction-associated steatohepatitis cirrhosis arm of its Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra in patients with compensated MASH cirrhosis.
The trial demonstrated significant reductions in liver stiffness, a surrogate for liver fibrosis, with patients showing a mean 6.7 kPa reduction after two years of treatment.
This reduction is the largest reported to date for a compensated MASH cirrhosis patient population.
Notably, 51 percent of patients achieved a 25% or greater reduction in liver stiffness, a key indicator linked to a lower risk of advancing to end-stage liver disease.
The study revealed that Rezdiffra, a selective thyroid hormone receptor-ß agonist, was well-tolerated, with a safety profile consistent with earlier trials.
The treatment showed a low rate of discontinuation due to adverse events, reinforcing its potential as a therapeutic option for this underserved population.
Rezdiffra in conjunction with diet and exercise was granted accelerated approval in March 2024 for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The drug generated net sales of $180.1 million for the full year 2024.
Becky Taub, Chief Medical Officer of Madrigal, highlighted the urgent need for treatment options in MASH cirrhosis patients, who face significantly higher risks of liver-related mortality.
She also emphasized that the ongoing Phase 3 MAESTRO-NASH OUTCOMES trial of Rezdiffra will further assess its efficacy and safety in compensated MASH cirrhosis, with the potential to become the first approved therapy for F2-F4c MASH.
The results from the MAESTRO-NAFLD-1 trial are a step forward in Madrigal's mission to improve care for patients with MASH cirrhosis, a condition that currently lacks FDA-approved treatments.
MDGL closed Tuesday's (Feb.25 2025) trading at $309.49 down by 3.93 percent. In premarket trading Wednesday the stock is up by 4.69 percent at $324.00 on the Nasdaq.
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