The trial win comes on the heels of the FDA's approval last week of Madrigal Pharmaceuticals' THR-β selective agonist Rezdiffra (resmetirom), the first drug waved through by US regulators to treat the liver disease. Cleared via the FDA's accelerated pathway, Rezdiffra is indicated for adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis consistent with stages F2 to F3 fibrosis. The drug hits the market next month at a US list price of $47,400 per year.
The current trial, dubbed CGZ203, tested two doses of chiglitazar monotherapy or placebo given once daily for 18 weeks to patients diagnosed with MASH. Chipscreen said the primary endpoint was met at both dose levels, producing "significant and dose-dependent reductions" in liver fat content compared to placebo after 18 weeks, based on MRI-proton density fat fraction (MRI-PDFF).
Both dose groups also showed "significant or dose-dependent trend of improvements" on secondary measures such as the proportion of patients achieving a >30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis, the company said. Chipscreen said "overall safety is good," and that further data analyses are underway.
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