NASH drug helps reduce liver fat with good tolerability
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Patients with non-alcoholic steatohepatitis treated with BIO89-100 experienced clinically meaningful reduction in liver fat, according to research presented at The Liver Meeting Digital Experience.
“We conducted a randomized, placebo-controlled trial using 89Bio’s glycoPEGylated FGF21 compound,” study investigator Rohit Loomba, MD, MHSc, director of the University of California, San Diego NAFLD Research Center told Healio Gastroenterology. “We looked at several different doses of FGF21 and also used weekly vs. every-two-weeks dosing.”
Researchers assessed the drug in a study comprising 81 patients who had liver fat of at least 10% measured by MRI-proton density fat fraction, and either biopsy-proven NASH or phenotypic NASH. They randomly assigned patients in cohorts that received one of six BIO89-100 doses (3, 9, 18 or 27 mg weekly, or 18 or 36 mg every two weeks) or placebo.
At week 13, every BIO89-100 group showed absolute and relative reductions in MRI-PDFF. Approximately 88% of patients treated with the drug achieved at least 30% reduction in MRI-PDFF compared with baseline (P < .001). Researchers also observed reductions in ALT and ProC3 among patients treated with BIO89-100.
“We, and others, have previously shown that if you achieve a 30%-reduction in MRI-PDFF, then the likelihood of showing histologic response, defined as a two-point improvement in NAFLD activity score or NASH resolution, is significantly increased,” Loomba said.
In the study, BIO89-100 also showed favorable tolerability. There were no deaths or related serious adverse events, while only one patient discontinued due to a related adverse event.
“With these data we are really excited,” Loomba said. “We think this drug has an important role.”
Perspective
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Jamile' Wakim Fleming, MD, FACG, FAASLD
In this study, Loomba et al. found that 88% of people treated with BIO89 had achieved a 30% reduction in fat. This finding is significant when extrapolated to another study in which resolution of 30% of fat on MRI-PD was shown to be highly likely associated with a two-point resolution of NASH.
MRI-PD is used in clinical trials only but has the advantage of being noninvasive and has a great potential in shedding more light on our understanding of fatty liver disease, despite it not being available for daily clinical use.
Medications used showed some resolution of fat. There is a need for trials that show regression of fibrosis and resolution of cirrhosis, the limiting steps in developing liver cancer and liver failure. Until then and until we have drugs with a very good safety profile, treatment of NASH livers will remain as is, lacking.
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