- Thinly traded micro cap Madrigal Pharmaceuticals (NASDAQ:MDGL) is up 45% premarket on light volume on the heels of its announcement of positive results from a Phase 2 clinical trial assessing lead candidate MGL-3196 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH).
- The study met its primary endpoint of a statistically significant reduction in liver fat from baseline as measured by an non-invasive imaging test called MRI-PDFF. Specifically, the change from baseline in MRI-PDFF in the overall treatment group was -36.3% versus -9.6% for placebo (p<0.0001).
- The percentage of patients achieving at least a 30% reduction in liver fat was 60.3% compared to 18.4% for placebo (p<0.0001). A 30% or more reduction in liver fat is associated with an improvement in NASH as determined by biopsy.
- Significant improvements in liver enzymes and lipids were also observed.
- MGL-3196's safety profile was favorable with most adverse events (AEs) considered mild. Three serious AEs were reported, none related to the study drug.
- The trial is ongoing. Additional data will be assessed at week 36. The estimated study completion date is March 2018.
- MGL-3196 is a once-daily, orally available, liver-directed selective thyroid hormone receptor-beta agonist.
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