Madrigal Pharmaceuticals' resmetirom is a leading treatment candidate for the advanced form of fatty liver disease.
Back around 2005, in a pharmaceutical research lab in Nutley, N.J., Becky Taub noticed something. She and other scientists at Roche CH:ROG were studying a molecule to see if it had potential as a treatment for diabetes or obesity. What Taub discovered was that the therapy, now called resmetirom, was instead removing fat from the livers of lab animals.
The drug is now one of two NASH therapies that may soon receive Food and Drug Administration approval at a time when around 13 million adults in the U.S. are thought to have the disease. Wall Street hopes that NASH drugs may help the battered biotech stock sector recover from its two-year slump, but there is also uncertainty about the potential costs of these therapies as well as concerns about access to drugs that treat a condition associated with obesity.
The other drug is Intercept Pharmaceuticals’ ICPT obeticholic acid, which is currently being reviewed by the regulator as a treatment for patients with pre-cirrhotic liver fibrosis due to NASH. A late-stage trial showed that the drug can treat the fibrosis that is common in NASH patients. The FDA’s decision on obeticholic acid is expected in June.
“That’s what we pick up as fat on biopsy,” said Meagan Gray, a transplant hepatologist who runs the University of Alabama at Birmingham’s nonalcoholic fatty liver disease clinic. “We recommend lifestyle modification and weight loss,” Gray said. “A small percentage of patients are able to achieve the weight loss that’s recommended with diet and exercise alone, and then an even smaller percentage is able to maintain that weight loss. But we want sustainable treatments that are going to help patients do well for the rest of their lives. So medication is definitely needed.
And Intercept, which announced Jan. 19 that the FDA had accepted the resubmission of its application for obeticholic acid for a NASH indication, has watched its own shares jump 36% over the last time period. The announcement came after the therapy suffered previous failures in clinical trials to treat fibrosis in NASH patients.
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