Pegozafermin, a potential treatment for improving fibrosis in NASH patients: Phase 2b Trial
USA: The positive outcomes of a phase 2b trial support the further advancement of pegozafermin into phase 3 trials for NASH treatment. If successful, pegozafermin could provide a much-needed therapeutic option for patients with NASH and potentially improve their long-term liver health.
The phase 2b clinical trial presented at the European Association for the Study of the Liver (EASL) Congress 2023 has demonstrated promising results for pegozafermin as a potential treatment for nonalcoholic steatohepatitis (NASH) patients with fibrosis.
The trial, simultaneously published in The New England Journal of Medicine, showed that more than 1-in-4 patients receiving 30 mg and 44 mg doses of pegozafermin met the criteria for fibrosis improvement, compared to only 7% in the placebo group. The parent company, 89 bio, has expressed plans to discuss the advancement of pegozafermin into phase 3 trials for NASH with regulatory agencies in the second half of 2023.
● The primary outcomes of interest were fibrosis improvement with no worsening of NASH at 24 weeks and NASH resolution without worsening of fibrosis at 24 weeks.
● Fibrosis improvement was defined as a reduction of at least one stage.
● The results showed that the proportion of patients achieving fibrosis improvement was significantly higher in the pegozafermin groups compared to the placebo group.
● Specifically, 26% of patients in the 30 mg pegozafermin group and 27% in the 44 mg pegozafermin group met the criteria for fibrosis improvement, compared to 7% in the placebo group.
● NASH resolution was also observed in a higher percentage of patients receiving pegozafermin compared to placebo.
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