89bio's Fatty Liver Candidate Shows Long-Term Improvement: Details

89bio Inc ETNB released topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH). 

At week 48, the 30mg weekly (QW) and 44mg every two weeks (Q2W) dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. 

The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.

Consistent with results observed in the Main Study, patients on background GLP-1 therapy who received pegozafermin continued to derive a greater benefit on markers of liver fibrosis, liver injury/inflammation, liver fat, and lipids, compared to patients who continued GLP-1 therapy in the placebo group.

The patients re-randomized to receive 30mg QW during the Extension Phase demonstrated improvements in NITs of liver fibrosis, liver injury/inflammation, and liver fat following 24 weeks of treatment with pegozafermin after experiencing minimal to no change during the first 24 weeks on placebo.

Pegozafermin continued to demonstrate a favorable safety and tolerability profile at week 48, consistent with previously reported data. The most common treatment-emergent adverse events were Grade 1 or 2 gastrointestinal events. 

Incidence rates of adverse events remained generally stable between week 24 and week 48 with no new patients on pegozafermin reporting diarrhea or nausea during the Extension Phase. 

At week 48, no clinically meaningful or statistically significant changes in bone mineral density or bone biomarkers were observed relative to placebo. No clinically meaningful or statistically significant blood pressure or heart rate changes were observed relative to placebo.

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