With the FDA approval of the first specific drug for Metabolic Associated Steatohepatitis (MASH) in March this year, Madrigal’s Rezdiffra is a pioneer in a market set for rapid change.
According to Spherix analysts, Rezdiffra “has seen rapid uptake,” with more than 60% of gastroenterologists and hepatologists surveyed in October 2024 by Spherix “indicating that they have prescribed the treatment.”
We’ve already seen this in Madrigal’s financials, where the biopharma reported $62 million in Rezdiffra sales last month for the quarter, exceeding expectations for this potential blockbuster.
But MASH remains a latent market, as just one approved drug leaves doctors with a “substantial unmet need.” According to Spherix’s recent Market Dynamix: MASLD/MASH U.S. study, conducted in May, 65% of gastroenterologists and hepatologists indicate “there is a high level of unmet need for new treatments in MASH.”
According to the American Liver Foundation, 1.5% to 6.5% of adults may be living with MASH in the U.S., with prevalence expected to increase by 65% by 2030.
“With numerous treatments currently in development, the MASH market is expected to see tremendous change in the coming years,” Spherix said in its report.
Spherix found that gastroenterologists are most familiar with GLP-1 inhibitors semaglutide from Novo Nordisk and Eli Lilly’s tirzepatide, both of which have type 2 diabetes and obesity licenses when it comes to MASH.
While neither are yet to have a specific license for MASH, but rather for certain patients with obesity, Spherix said “this is not surprising,” given that a “notable portion” of MASH patients are already being treated with a GLP-1 who also have type 2 diabetes or obesity.
But MASH licenses for the drugs may be coming.
Spherix points to recent data from Novo Nordisk showing that semaglutide met its primary endpoints in its phase 3 ESSENCE trial, including a statistically significant improvement in liver fibrosis compared to placebo in MASH patients.
This has teed up an FDA filing for the ever-popular med, though analysts at Evercore ISI writing in a note to clients at the end of October said that they still expect Rezdiffra to continue to grow through a potential launch of Novo’s drug in MASH.
Overall, “this is a large market with room for many players and treatment options,” the Evercore team said.
Meanwhile, William Blair analyst Andy Hsieh, Ph.D., said in a note that Novo’s semaglutide readout is largely on par with the magnitude of fibrosis improvement shown by Rezdiffra, noting that the results have “practice-changing potential.”
Hsieh’s team said that investors are now rallying around the potential of GLP-1s like semaglutide in MASH, citing recent promising results from Eli Lilly’s tirzepatide and Boehringer Ingelheim’s survodutide (a dual GLP-1/glucan agonist) in the disease.
“We believe the consensus view within the investment community is that the GLP-1 receptor agonist class will likely be incorporated into the treatment paradigm for MASH,” Hsieh wrote in a note to clients after the Novo data drop.
In staking that claim, Hsieh also noted that Viking Therapeutics is uniquely positioned in the field, thanks to the fact that the biotech is developing both a liver-directed candidate (VK2809) with the same mechanisms as Rezdiffra and a dual GLP-1/GIP agonist (VK2735) that shares its mode of action with Lilly’s tirzepatide.
