The blockbuster Novo Nordisk weight problems drug Wegovy has met the primary targets of a pivotal check in metabolic dysfunction steatohepatitis, or MASH, outcomes the drugmaker says help increasing the product’s label to incorporate this prevalent fatty liver illness.
MASH is a metabolic dysfunction wherein the buildup of liver fats results in worsening operate of the organ. In superior circumstances, sufferers require a liver transplant. Greater than 250 million folks worldwide are estimated to have MASH. Wegovy’s essential ingredient is semaglutide, an engineered peptide that binds to the GLP-1 receptor to spark metabolic results. Semaglutide was initially permitted for treating kind 2 diabetes, the place the drug is marketed as Ozempic.
The preliminary outcomes reported Friday are from a placebo-controlled Part 3 scientific trial enrolling 1,200 contributors who’ve MASH with moderate-to-advanced liver scarring, also called fibrosis. After 72 weeks, Novo Nordisk stated 37% of people that acquired once-weekly injections of Wegovy on high of normal of care confirmed enchancment in liver fibrosis with no worsening of the fatty liver illness. For many who acquired a placebo and customary care, 22.5% achieved this aim.
Novo Nordisk additionally stated 62.9% of sufferers within the Wegovy group achieved decision of the fatty liver illness with no worsening of liver fibrosis. By comparability, 34.1% of these within the placebo group achieved this aim. The corporate stated the outcomes had been sufficient to be statistically important. On measures of security and tolerability, Novo Nordisk stated Wegovy was similar to earlier assessments of the drug. The corporate stated extra element will probably be offered at a medical convention later this 12 months.
The most recent outcomes are from Half 1 of a two-part research Part 3 research. The second half is evaluating how nicely Wegovy lowers the chance of liver-related scientific occasions in comparison with a placebo at 240 weeks. Novo Nordisk expects Half 2 of the research will put up information in 2029. However primarily based on the scientific information thus far, the corporate expects to file purposes looking for U.S. and European Union approval in MASH within the first half of subsequent 12 months.
In a observe despatched to buyers Friday, Leerink Companions analyst Thomas Smith wrote that the information readout is essentially according to the agency’s best-case state of affairs — statistically important enchancment in fibrosis, however not a game-changing outcome. Leerink believes this class of peptide medicine have utility addressing some points of MASH together with the illness’s comorbidities, reminiscent of weight problems, kind 2 diabetes, and heart problems. Nevertheless, Smith stated the information verify Leerink’s thesis that these medicine “don’t symbolize a ‘silver bullet or purposeful remedy for [MASH] sufferers with superior fibrosis, and over the long run, we count on polypharmacy and mixture use will develop into customary of care.”
Within the view of William Blair analyst Andy Hsieh, the magnitude of fibrosis enchancment is much like that achieved by Rezdiffra, the Madrigal Prescribed drugs drug that grew to become the primary FDA-approved MASH remedy earlier this 12 months. The placebo-adjusted enchancment in fibrosis with no worsening of illness for Rezdiffra, a once-daily capsule, was 12% in comparison with 14% for once-weekly injectable Wegovy.
Earlier this 12 months, Eli Lilly and Boehringer Ingelheim every posted encouraging scientific trial outcomes for his or her potential MASH therapies. Hsieh stated the consensus view inside the funding group is that the GLP-1 receptor agonist class will probably be integrated into the remedy paradigm for MASH.
“It’s our view that right this moment’s improvement provides to the rising physique of proof in help of that pattern,” Hsieh stated.
Picture: Michael Siluk/UCG/Common Photos Group, through Getty Photos
