89bio, Inc. (NASDAQ: ETNB) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of treatments for liver and cardiometabolic diseases. Shares of the biopharma company are soaring 31% through early trading on Wednesday, March 22, 2023. Over the past three months, 89bio has seen average daily volume of 1.11 million shares. However, volume of 17.22 million shares or dollar volume of around $252.45 million, has already exchanged hands through early trading.
Shares of 89bio are rallying after the company reported positive topline data from its Phase 2b ENLIVEN clinical trial of pegozafermin as a treatment for nonalcoholic steatohepatitis (NASH). During the clinical study, both the 44mg every-two-week (Q2W) and 30mg weekly (QW) doses demonstrated high statistical significance in the reduction of fibrosis without worsening NASH.
The 44mg Q2W demonstrated a 27% one-stage fibrosis improvement, while the 30mg QW group saw a 26% improvement. Both test groups vastly outperformed the placebo group, which only had a 7% rate of fibrosis improvement. Three expert, independent, and blinded pathologists scored the ENLIVEN study biopsies to ensure no biases.
89bio’s strong results from the Phase 2b ENLIVEN trial demonstrates pegozafermin as a potential treatment every-two-weeks to treat chronic and asymptomatic NASH. The strong results from the Phase 2b trial warrants an upgrade to a Phase 3 trial to further explore the different dosing and its impact on NASH.
“Our vision has been to develop a therapy that addresses the liver and cardiometabolic manifestations of this complex liver disease and do so in a well-tolerated and convenient way for seamless integration into patient lives,” said Hank Mansbach, Chief Medical Officer of 89bio. “These data demonstrate that we are on our way to making this vision a reality and highlight pegozafermin’s potentially differentiated profile based on its efficacy and tolerability results to date and convenient dosing interval. We are pleased to see that every-two-week dosing produced remarkably similar results to weekly dosing, which is expected to provide us optionality as we work with the FDA to advance pegozafermin into Phase 3 development.”
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