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Aldafermin (NGM282) is an engineered FGF-19 similar that, in a previously published 12-week study, significantly inhibited bile acid synthesis and reduced liver fibrosis, inflammation, and fatty degeneration.
researchers recently published the full results of Aldafermin's clinical study on the treatment of non-alcoholic fatty hepatitis (NASH) Phase II.
The study was conducted in 9 U.S. centers with 78 NASH patients who received a biopsy that confirmed non-alcoholic fatty liver activity scores ≥4, 2 or 3 fibrosis, MRI absolute liver fat content ≥8 percent), and random placebo (n-25) or aldafermin (n-53, 1mg daily) treatment for 24 weeks.
of the study was 24 weeks, the absolute liver fat content changed compared to the baseline, with secondary endpoints including serological and histological fibrosis and NASH improvement.
24 weeks, the absolute liver fat content of the aldafermin group was reduced by 7.7 percent compared to the baseline, while the placebo group was reduced by 2.7 percent.
aldafermin therapy was better than placebos in reducing 7 alpha-hydroxy-4-cholesterol-3-ketones, bile acid, alanine and tyrosine transaminase, and Type III. collagen pre-peptides (Pro-C3).
38 percent of patients in the aldafermin treatment group had more than 1 level of fibrosis and no NASH symptoms, while only 18 percent in the placebo group.
of patients with NASH remission and no increase in fibrosis were 24 percent in the aldafermin treatment group and 9 percent in the placebo group.
patients in the aldafermin treatment group withdrew from the study due to adverse events, and 4% of patients in the placebo group withdrew from the study due to adverse events.
Phase II study confirmed that aldafermin reduced liver fat content and improved fibrosis in patients with non-alcoholic fatty hepatitis.