A Phase 2 clinical trial assessing Madrigal Pharmaceuticals’ (NASDAQ:MDGL) MGL-3196 in patients with non-alcoholic steatohepatitis (NASH) met the primary endpoint at week 12 and demonstrated a sustained treatment benefit at week 36.
39% of the responders at week 12 experienced complete resolution of NASH at week 36 compared to 6% for placebo (p=0.001). Fibrosis was resolved in half the patients.
Mean liver fat reduction was 37.0% in the treatment group compared to 8.9% for placebo.
No new safety signals were observed.
A larger Phase 3 with a longer treatment period is next up.
May 31, 2018