S3-E60.5 - Madrigal Announcement on Resmetirom: Combination Therapy and Closing Takeaways

Send us Fan MailIn a monumental moment in the never-ending pursuit of putting a major dent in Fatty Liver disease, Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH clinical trial of resmetirom for the treatment of NASH and liver fibrosis. Madrigal’s leadership intends to file for resmetirom’s accelerated approval with the FDA in the first half of 2023. If approved, the drug may become the first NASH medication introduced to market, depending on the outcome and timing of Intercept Pharmaceuticals’ refiling of obeticholic acid.To recognize this special occasion, Surfing the NASH Tsunami hosts its largest ever suite of panelists who react to the enthusiasm, synergy and implications surrounding the news. This final conversation starts with Roger Green following up on a couple of earlier comments. First, he notes the fact that in other diseases, a combination therapy can get approved before each element of monotherapy has been approved. Second, he notes that semaglutide’s Phase 2 result, with 72-week effects on steatosis and NAS activity score but not fibrosis regression, aligns with Scott Friedman’s earlier statement that not all fat lowering may mean the same thing in the liver. Jörn Schattenberg and Mazen Noureddin follow-up with other comments about NAS, fibrosis and lipotoxicity. This leads Jörn to note that there is already a second THR-beta in trial, from Viking Therapeutics, and asks what this trial might mean for Viking. Mazen cites Terns as another company with other drugs, including a THR-beta in the pipeline, and believes they will benefit as well. Scott asks what all this means for patients with cirrhosis. Rachel Zayas then discusses some of the development work her company is doing and how these results might affect her work and ability to raise resources. As the session winds down, Kris Kowdley describes one more way that the use of companion diagnostics against dose response and non-response will aid payers. For her final thoughts, Louise Campbell discusses how we might consider this a major anti-cancer advance given how the liver is implicated not only in HCC but also in non-hepatic cancers. Surf on to hear the diverse array of closing takeaways from the rest of the group.