today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH.
Pegozafermin for NASH and fibrosis: phase IIb resultsLiver fibrosisNon-alcoholic steatohepatitisdoi:10.1038/s41575-023-00825-9Eleni,KotsilitiNature Publishing Group UKNature reviews. Gastroenterology & hepatology
significantly improved fibrosis without worsening ofnonalcoholic steatohepatitis(NASH) and led to resolution of NASH without worsening of fibrosis for patients with noncirrhotic disease, according to late-breaker results of thephase 2b ENLIVEN trial. The results were presented at the European Association ...
Methods This proof‐of‐concept, open‐label, single‐cohort study, part 2 of a phase 1b/2a clinical trial, was conducted at 16 centres in the United States. Adults (age 21–75?years) with NASH (stage 2 or 3 fibrosis, NAS≥4) and magnetic resonance imaging proton density fat fraction...
89bio, Inc. today announced that data from the 48-week extension phase of the Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will ...
The efficacy and safety of pegozafermin in patients with biopsy-proven noncirrhotic NASH are not well established.Methods Download a PDF of the Research Summary.In this phase 2b, multicenter, double-blind, 24-week, randomized, placebo-controlled trial, we randomly assigned patients with biopsy-...