Madrigal Pharmaceuticals announced that on Thursday, April 11, at the International Liver Congress 2019, European Association for the Study of the Liver in Vienna, further in depth analyses of the Phase 2 NASH study with MGL-3196 will be presented. Resmetirom is currently in Phase 3 development for the treatment of NASH patients with stage 2-3 fibrosis. MGL-3196-05 was a 36-week multicenter, randomized, double-blind, placebo- controlled serial MRI-PDFF, paired liver biopsy study in adults with biopsy-confirmed NASH and hepatic fat fraction greater than or equal to10%. In 12 week interim and 36 week final analyses, MGL-3196 treated patients had significantly more reduction of liver fat compared with placebo on MRI-PDFF and up to 77% of resmetirom-treated patients showed at least a 30% reduction of liver fat. NASH resolution was attained on biopsy in 39% of resmetirom patients who had a positive PDFF response. At 36 weeks 107 paired biopsies were assessed to examine the predictive power of PDFF response on histologic response of NAS, NASH resolution and reduction of ALT. In resmetirom-treated patients, a 12 week PDFF response versus non-response was predictive of NASH resolution at week 36 and correlated with improvements in steatosis, hepatocyte ballooning and inflammation as well as reduction in ALT. Placebo patients with weight loss greater than or equal to5% were likely PDFF responders, and a PDFF response in placebo patients also predicted reductions in inflammation and hepatocyte ballooning. Dr. Harrison stated, “These analyses show that positive MRI-PDFF responses correlate with reductions in hepatocyte ballooning, inflammation and NASH resolution on liver biopsy and are associated with decreases in ALT. The data suggest that reduction of hepatic fat is a critical component of NASH improvement and resolution.”
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