89bio: Phase 2b ENLIVEN Trial Of Pegozafermin In Patients With NASH Meets Primary Goals

89bio, Inc. (ETNB), a clinical-stage biopharmaceutical company focused on liver and cardiometabolic diseases, announced Wednesday positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis or NASH.

The company said the positive data from this rigorous trial supports advancement to Phase 3 trial.

In pre-market activity on Nasdaq, 89bio shares were gaining around 49 percent to trade at $16.28.

In the study, both the 44mg every-two-week or Q2W and 30mg weekly or QW doses met, with high statistical significance, both the primary histology endpoints per the U.S. Food and Drug Administration guidance on endpoints and statistical analysis.

NASH is a chronic and often asymptomatic disease.

The company noted that both 44mg Q2W and the 30mg QW dose groups 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.

Rohit Loomba, Director, NAFLD Research Center, University of California San Diego, and lead investigator of ENLIVEN, said, "The treatment effect and highly statistically significant results observed across the two FDA approvable histology endpoints is very encouraging and clearly support advancement into Phase 3 development. These data are amongst one of the most consistent data sets for drugs in clinical development for NASH with a parallel improvement in both MRI-PDFF and ALT, and bodes well for the likelihood of success in the upcoming Phase 3 program."

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