molecules of the month

A first-in-class drug for NASH? Resmetirom, an oral, liver-targeting, once-daily THR-β-selective agonist, recently made headlines for meeting both primary surrogate endpoints in an early Ph. III readout for NASH, demonstrating NASH resolution and no worsening of fibrosis by biopsy after 52 weeks in 26% of patients at 80 mg QD (n=316) vs. 10% for placebo (n=318), and demonstrating improvement in fibrosis with no worsening of NASH (24% at 80 mg vs. 14% for placebo). These unexpectedly positive results skyrocketed the valuation of Madrigal (MDGL) to over $5B. Resmetirom could become the first drug to achieve accelerated approval for NASH, with an NDA to be filed in ‘23. Why is this a big deal? Non-alcoholic steatohepatitis (NASH) impacts an estimated 3-5% of…