Pegbelfermin an effective medicine for Non-Alcoholic Fatty Liver disease, shows Trial
USA: Treatment with Pegbelfermin significantly reduced hepatic fat fraction in non-alcoholic steatohepatitis (NASH) patients, according to a phase 2a trial published in the journal Lancet. No medicines have been approved to treat NAFLD and NASH till now.
Non-alcoholic steatohepatitis is a form of fatty liver disease that is characterized by hepatic necroinflammation, progression of fibrosis, and a strong association with metabolic syndrome and is increasing as a cause of morbidity and mortality.
Pegbelfermin, a PEGylated human fibroblast growth factor 21 (FGF21) analog, has previously been shown to improve markers of metabolism and liver fibrosis in obese patients with type 2 diabetes. In this phase 2a study, Edgar D Charles, Bristol-Myers Squibb, Lawrenceville, NJ, USA, and colleagues aimed to evaluate the safety and efficacy of pegbelfermin in 75 NASH patients: 25 assigned to pegbelfermin 10 mg once a day, 24 assigned to pegbelfermin 20 mg once a week and 26 assigned to placebo.
Study enrollment was ended prior to enrolling the planned sample size of 30 patients per group because of a significant effect of pegbelfermin on hepatic fat fraction during the interim analysis at treatment week 8.
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- After 16 weeks of treatment, mean hepatic fat fraction dropped by 6.8% with pegbelfermin once daily, by 5.2% with pegbelfermin once weekly and by 1.3% compared with placebo.
- Most patients treated with pegbelfermin developed anti-pegbelfermin and anti-FGF21 antibodies, but titers were generally low and not associated with immune-related adverse events.
- Pegbelfermin treatment was also associated with significant improvements in adiponectin concentration and with significant decreases in PRO-C3, a biomarker of fibrosis.
- Mean concentrations of alanine aminotransferase and aspartate aminotransferase decreased with pegbelfermin treatment, as did mean liver stiffness as measured by magnetic resonance elastography (MRE).
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"Treatment with subcutaneously administered pegbelfermin for 16 weeks was generally well tolerated and significantly reduced hepatic fat fraction in patients with non-alcoholic steatohepatitis. Further study of pegbelfermin is warranted in patients with non-alcoholic steatohepatitis." concluded the authors.
For further reference log on to https://doi.org/10.1016/S0140-6736(18)31785-9