NASH drug helps reduce liver fat with good tolerability
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.”