Market Assessment
Madrigal (NASDAQ:MDGL) is a mid-cap ($2B) founded in 2011 by Dr. Rebecca Taub, the current Chief Medical Officer. Since its reverse merger with Synta Pharmaceuticals in early Q3/2016, Madrigal has meticulously demonstrated through its clinical program why its clinical stage status may soon be upgraded to commercial stage. Its focus on developing therapeutics for the preventive and treatment of cardiometabolic disorders of high unmet medical needs is being validated through its lead investigative drug candidate, MGL-3196 or resmetirom.
MGL-3196 is a first-in-class, orally-administered, small-molecule protein that is eliminated mainly in feces through the bile. Radiographic analysis has shown that MGL-3196 is a liver-directed, Thyroid Hormone Receptor (THR)-β-selective agonist with negligible expression in the heart, bone, and brain.
In the Phase 2b NASH study, Madrigal clearly demonstrated via MGL-3196 the critical role of liver fat in driving NASH pathogenesis and ensuing liver fibrosis. The study showed that patients with ≥30% liver fat reduction, in response to MGL-3196 treatment, always attained greater medical benefits, including histological NASH resolution and regression of liver fibrosis. The notable total regression of liver fibrosis (i.e. normalization of liver) in some patients that achieved NASH resolution is a correlation and confirmation of Madrigal thesis that treating NASH is key to addressing the disease and related pathological events.
Recently, Madrigal provided further data analysis on the clinical benefits of liver fat reduction and weight loss in NASH resolution. In the press release, placebo patients with weight loss ≥5% were most likely to achieve ≥30% hepatic fat reduction that correlated with reductions in inflammation and hepatocyte ballooning that induces NASH resolution. Madrigal's study confirms a previous report that correlates weight loss with NASH resolution. They concluded that liver fat reduction is a critical component in NASH improvement and resolution. These findings are very encouraging for the medical communities
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