: Inside the NASH drug boom: New drugs for a ‘silent’ liver disease that affects millions near FDA approval

by | Feb 13, 2023 | Stock Market

Back around 2005, in a pharmaceutical research lab in Nutley, N.J., Becky Taub noticed something. She and other scientists at Roche
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.

At that time, there was growing interest in better understanding nonalcoholic fatty liver disease (NAFLD), a range of conditions that occurs when excess fat builds up in liver cells. An estimated 25% of Americans have NAFLD, while about 20% of those patients end up developing a more severe version called nonalcoholic steatohepatitis (NASH), in which the inflammation and cell damage caused by the fat buildup can cause cirrhosis and liver failure.  NASH is one of the top reasons people in the U.S. need liver transplants.  “Most of these patients are diabetic, and most of them are obese,” said Taub, who is now co-founder and chief medical officer at Madrigal Pharmaceuticals
which is developing resmetirom as a treatment for NASH. “They also have high blood pressure. They have elevated cholesterol and triglycerides. It’s this whole spectrum of metabolic diseases.” As the medical community began to better understand NASH, so did scientists like Taub, who began a two-decade effort shepherding resmetirom through the scientific and regulatory process — first by acquiring the drug from Roche, then by co-founding Madrigal in 2011 and then, five years later, setting up a reverse merger with Synta Pharmaceuticals that gave Madrigal the funding it needed to get resmetirom into a Phase 2 study.  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. Wal …

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