KENILWORTH (NJ) (dpa-AFX) - Merck (MRK) reported positive Phase 2b results for Efinopegdutide, an investigational treatment for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease that can lead to cirrhosis, liver failure and other serious complications.
MASH affects millions of people worldwide and is characterized by fat buildup, inflammation and scarring in the liver. Treatment options remain limited, particularly for patients with more advanced liver fibrosis.
The Phase 2b study evaluated three once-weekly doses of Efinopegdutide in adults with biopsy-confirmed MASH and stage F2 or stage F3 liver fibrosis. The trial met its primary endpoint, demonstrating significantly higher rates of MASH resolution without worsening fibrosis after 52 weeks compared with placebo.
MASH resolution was achieved in 56% 63% and 61% of patients receiving the 4 mg, 7 mg, and 10 mg doses, respectively, versus 13% for placebo.
The study also showed improvement in liver scarring. A key secondary endpoint measuring at least a one-stage improvement in fibrosis without worsening liver inflammation was achieved by 43%, 52% and 34% of patients across the three dose groups, compared with 21% of patients receiving placebo.
The trial enrolled 386 adults with MASH and stage F2 or F3 fibrosis. Participants received either Efinopegdutide, placebo or an active reference treatment of semaglutide 2.4 mg, with 92% completing the study.
Efinopegdutide's safety profile was generally consistent with that of GLP-1 based therapies. The most common side effects were gastrointestinal, including nausea, diaarhea, and vomiting. Discontinuation rates due to adverse events ranged from 3% to 11% across the Efinopegudutide groups; compared with 1% for both placebo and semaglutide.
Efinopegdutide is a once-weekly injectable dual GLAP-1/glucagon receptor co-agonist designed to combine appetite regulation and metabolic benefits with direct effects on liver fat metabolism. The drug has received FDA Fast Track Designation for MASH.
The results were presented at The Liver Meeting (TLM) and published simultaneously in The Lancet, supporting Merck's continued development of Efinopegudutide as a potential treatment option for patients with MASH and liver fibrosis.
MRK has traded between $85.80 and $156.92 over the past year. The stock closed Monday's trading at $148.76, up 1.38%. During overnight trading the stock is at $149.60, up 0.56%.
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