A study performed by US experts looked into a potential new treatment option for individuals with nonalcoholic steatohepatitis (NASH)-related fibrosis.
The findings, which were published in the online edition of The New England Journal of Medicine, detail a medicine called Pegozafermin, which mimics a hormone in the body and improves both liver fibrosis and liver inflammation in NASH patients.
“Identifying an effective drug for NASH is extremely promising for patients as currently there are no FDA-approved therapies for this condition,” said Rohit Loomba, the study’s first author and chief of the Division of Gastroenterology and Hepatology at University of California-San Diego School of Medicine.
“NASH can adversely impact the quality of life in patients and can progress to cirrhosis. Its complications can lead to death or liver transplantation.
“Our findings will further the science of this disease and provide a potential new treatment option to those affected by NASH-related fibrosis,” Loomba said.
According to the researchers, Pegozafermin mirrored fibroblast growth factor 21 (FGF21), a naturally occurring peptide hormone released by the liver.
FGF21 regulates energy metabolism in the organism as well as lipid metabolism in the liver. Previous research has also demonstrated that it lowers blood glucose and insulin levels, as well as body weight and liver fat.
“The study’s results show that the new potential treatment not only improves fibrosis but also improves inflammation and liver injury along with significant improvements across multiple non-invasive biomarkers of NASH activity and scarring,” Loomba said.
The 24-week, randomized clinical trial included 222 NASH patients who were randomly allocated to either the medication or a placebo.
Approximately 27% of patients who received the medicine at a higher dose exhibited an improvement in liver fibrosis, compared to 7% of patients who received the placebo. The drug’s most often reported adverse effects were gastrointestinal in nature, such as nausea.
There are currently no FDA-approved drugs available for the treatment of NASH, which is a form of nonalcoholic fatty liver disease (NAFLD).
The next phase in this research, according to Loomba, will be a bigger, multi-center, multinational trial with a more diversified patient group and a longer treatment time to properly examine the drug’s safety.
“If successfully shown to be both safe and effective in a larger Phase 3 trial, this drug could be used to treat millions of patients with NASH,” Loomba noted.