FRIDAY, June 30, 2023 (HealthDay News) — For patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage F2 or F3 fibrosis, treatment with pegozafermin leads to improvements in fibrosis, according to a study published online June 24 in the New England Journal of Medicine to coincide with the annual congress of the European Association for the Study of the Liver, held from June 21 to 24 in Vienna.
Rohit Loomba, M.D., from the University of California in San Diego, and colleagues conducted a multicenter, randomized phase 2b trial involving patients with biopsy-confirmed NASH and stage F2 or F3 fibrosis (moderate or severe). A total of 222 participants were randomly assigned to receive subcutaneous pegozafermin (15 or 30 mg weekly or 44 mg every two weeks) or placebo weekly or every two weeks; 219 participants received pegozafermin or placebo.
The researchers found that the percentage of patients who met the criteria for fibrosis improvement was 7, 22, 26, and 27 percent in the pooled placebo group, the 15-mg, 30-mg, and 44-mg pegozafermin groups, respectively. The corresponding percentages of patients who met the criteria for NASH resolution were 2, 37, 23, and 26 percent. Nausea and diarrhea were the most common adverse events associated with pegozafermin therapy.
“Pegozafermin treatment for 24 weeks led to improvements in fibrosis with both weekly and every-two-week administration in patients with biopsy-confirmed NASH,” the authors write. “A potential for administration once every two weeks may increase patient convenience and adherence to treatment.”
Several authors disclosed ties to biopharmaceutical companies, including 89bio, which developed pegozafermin and funded the study.
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