89bio’s pegozafermin trial statistically significant in critical histology

89bio announced positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis NASH . In the study, both the 44mg every-two-week Q2W) and 30mg weekly QW doses met, with high statistical significance, both the primary histology endpoints per the U.S. Food and Drug Administration FDA guidance on endpoints and statistical analysis.The 44mg Q2W and the 30mg QW dose groups both demonstrated at least one-stage fibrosis improvement without worsening of NASH at 3.5 times the placebo rate and NASH resolution without worsening of fibrosis between 12 to 14 times the placebo rate. The ENLIVEN study biopsies were scored independently by three expert blinded pathologists to minimize individual reader bias and inter-reader variability"I was pleased to see the impressive results on the critical histology endpoints and non-invasive tests in the ENLIVEN trial. I was especially encouraged by the significant improvement in fibrosis relative to placebo, as fibrosis is a key driver of NASH disease progression which can lead to cirrhosis and other negative clinical outcomes," said Arun J. Sanyal, MBBS, M.D., Professor, Departments of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University. "These data are all the more significant given the rigor of the study methodology, including how the biopsies were read to reduce the impact of reader bias and variability. The ENLIVEN study followed a stringent analytical plan consistent with FDA guidance, and the low placebo response rate provides high confidence that this trial showed the true potential treatment effect of pegozafermin."