Madrigal Pharmaceuticals Inc. (NASDAQ: MDGL) reported positive top-line results from its Phase 2 clinical trial for a liver disease therapy. Shares skyrocketed over 150 percent after Wednesday’s close and continued to rise throughout Thursday.
Madrigal therapy is used to treat patients with biopsy-proven nonalcoholic steatohepatitis or NASH. In the trial, the therapy showed significant improvements in the primary endpoint, resulting in relative reduction of liver fat on the magnetic resonance.
NASH affects about 3 percent to 12 percent of U.S. adults. It is caused by too much fat store in the liver which can lead to liver inflammation and live damage, which can cause liver scarring, permanent damage or even live cancer, according to the National Institutes of Health.
The pharma said the therapy showed significant improvements by week 36 and that it was found to have met a primary endpoint at 12 weeks.
“The degree of NASH resolution, an approvable FDA endpoint, in patients who received MGL-3196 for 9 months we believe suggests a high likelihood of success in a larger trial with a somewhat longer treatment period in a Phase 3 study designed similarly to this Phase 2 study, pending regulatory agreement with such a design.” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal.
“Further, considering what we have learned regarding drug exposure and dosing, we believe there is potential to resolve NASH in as little as 9 months in 30-40% of patients receiving only MGL-3196, a well-tolerated once a day oral therapy.” added Friedman.