Results

Madrigal’s stock soars on promising PhII data in NASH, but questions linger

The stock is flying for Madrigal Pharmaceuticals following news that its fatty liver disease drug successfully pared down liver fat in Phase II trials. Shares jumped more than 100% Wednesday morning as the Philadelphia company preps to compete with titans in the space.

Madrigal $MDGL, which merged with cancer drug maker Synta Pharmaceuticals last year, is developing small molecule drugs in cardiovascular-metabolic diseases and the hot (and increasingly crowded) field of non-alcoholic steatohepatitis (NASH).

Paul Friedman

This new data is on Madrigal’s lead compound MGL-3196, a once-daily pill for NASH that works as a liver-directed selective thyroid hormone receptor β-selective agonist.

NASH, a chronic liver disease caused by fat build-up in the liver, affects around 15 million people in the US. It can lead to fibrosis, or scarring, in the liver, which can cause liver failure and cancer. The field is a big target for the biopharma industry, and companies like Madrigal face major competition from the likes of Gilead, Allergan, Bristol-Myers Squibb, and others.

Madgrial’s Phase II data is promising, with the drug causing a statistically significant reduction in liver fat (-36.3%) for patients taking MGL-3196 compared to patients on the placebo (-9.6%).

But some analysts say fat reduction in the liver won’t necessarily set NASH drug makers apart from competition. Instead, the key would be to reduce scarring alongside liver fat. Madrigal said that’s one of its secondary endpoints: improvement in fibrosis by at least one stage with no worsening steatohepatitis. The company said multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks “are being and will be assessed.” Results are expected in Q2 of 2018, the company said in a statement.

“We are gratified to see clinical results that strongly suggest MGL-3196 has the potential to provide clinically meaningful improvement of NASH by targeting lipotoxicity and inflammation as well as by reduction of cardiovascular risk by lowering atherogenic lipids,” said Paul Friedman, CEO of Madrigal, in a statement. “These pleiotropic actions, coupled with the excellent safety profile we have seen in this trial, continue to suggest that MGL-3196 has the potential to address the root causes of the underlying disease process in NASH.”



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