Cellicon Valley companies closed out 2022 with a roar. Madrigal Pharmaceuticals announced a breakthrough in NASH that could result in the first-approved drug for that disease. Galera Therapeutics closed out December with plans to seek approval for its severe oral mucositis therapy.
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced initiation of the “MAESTRO-NASH Outcomes” study of resmetirom (recruiting, first patient screened). MAESTRO-NASH Outcomes is a Phase 3, double-blind, randomized, placebo-controlled study that will noninvasively measure progression to liver decompensation events in approximately 700 patients with compensated NASH cirrhosis. It is the fourth Phase 3 MAESTRO study of resmetirom, joining the MAESTRO-NAFLD-1 safety study, which reported positive data in January 2022, the ongoing MAESTRO-NAFLD Open-Label Extension study, and the pivotal MAESTRO-NASH biopsy study, which is on track for a topline data readout in Q4 2022.
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced data from multiple resmetirom abstracts presented at the European Association for the Study of the Liver’s International Liver Congress (EASL 2022), including a late-breaking presentation of data from the Phase 3 MAESTRO-NAFLD-1 study and three additional oral presentations from the resmetirom clinical development program.