Madrigal Pharma's Kidney Disease Candidate Improves Liver, Cardiovascular Health

Madrigal Pharmaceuticals Inc MDGL has announced topline data from Phase 3 MAESTRO-NAFLD-1 safety study of resmetirom. 

• The 52-week study demonstrated that resmetirom was safe and well-tolerated at 80 and 100 mg once a day dosing. 
• Additionally, resmetirom helped patients with presumed non-alcoholic steatohepatitis (NASH) achieve significant, clinically relevant reductions in liver fat and atherogenic lipids.
• A total of 972 patients were randomized in the double-blind arms of the MAESTRO-NAFLD-1 (non-alcoholic fatty liver disease) study.
• Adverse events observed in the trial were generally mild to moderate in severity. 
• The most common adverse event reported with greater frequency in the resmetirom groups vs. placebo was generally mild diarrhea or increased stool frequency at the beginning of therapy, which occurred in 9% and ~17% over the placebo rate in the 80 and 100 mg dose groups, respectively.
• Madrigal will continue to generate data from the MAESTRO-NAFLD-1 study, with future readouts of safety, additional biomarkers, and non-invasive measures of liver fibrosis. 
• Price Action: MDGL shares are up 14.8% at $64.75 during the premarket session on the last check Monday.