The findings, published online in the New England Journal of Medicine, describe a drug called Pegozafermin that mimics hormones in the body to improve fibrosis, or liver scarring, and liver inflammation in patients with NASH.
UPDATE – Tuesday 27 March 03:25 pm
New York: US researchers led a study looking at a potential new treatment option for patients with fibrosis associated with nonalcoholic steatohepatitis (NASH).
The findings, published online in the New England Journal of Medicine, describe a drug called Pegozafermin that mimics hormones in the body to improve fibrosis, or liver scarring, and liver inflammation in patients with NASH.
“Finding an effective drug for NASH is very promising for patients, as there are currently no FDA-approved treatments Therapies for this disease.” School of Medicine.
“NASH can adversely affect patients’ quality of life and can progress to cirrhosis. Complications can lead to death or liver transplantation.
“Our findings will further advance the science of this disease and provide potential new treatment options for those affected by NASH-related fibrosis,” Loomba said.
Pegozafermin mimics fibroblast growth factor 21 (FGF21), a liver-secreted peptide hormone that is naturally produced in the body, the researchers said.
FGF21 controls energy expenditure in the body and lipid metabolism in the liver. Previous studies have also shown that it lowers blood sugar and insulin levels, and reduces body weight and liver fat.
“The findings suggest that new potential therapeutics can improve not only fibrosis, but also inflammation and liver injury, and significantly improve multiple non-invasive biomarkers of NASH activity and scarring,” Loomba said.
The 24-week randomized clinical trial involved 222 participants with NASH who were assigned to receive the drug or a placebo.
Liver fibrosis improved in about 27 percent of patients who received the higher dose of the drug, compared with 7 percent of patients who received a placebo. The most common drug side effects were gastrointestinal side effects, including nausea.
Currently, there are no FDA-approved medications for the treatment of NASH, a type of nonalcoholic fatty liver disease (NAFLD).
Loomba added that the next step for this research will be a larger, multicenter international trial involving a more diverse patient population and a longer treatment period to better assess the drug’s safety profile.
“If the drug is successfully shown to be safe and effective in a larger phase 3 trial, the drug could be used to treat millions of patients with NASH,” Loomba noted.
