89bio, Inc. announced the presentation of additional data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) at the American College of Cardiology's 72nd Annual Scientific Session & Expo Together with World Congress of Cardiology (ACC.23/WCC). The presentation featured results of a post hoc analysis exploring the effect of pegozafermin treatment on lipids among study participants based on their background lipid-modifying therapy (LMT) status. These results were presented by Deepak L. Bhatt, M.D., M.P.H., Director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, and a copy of the poster is accessible under ‘Scientific Publications' in the pipeline section of 89bio's website.

The company previously announced that the randomized, double-blind ENTRIGUE trial met the primary endpoint of statistically significant reductions in median TGs from baseline in patients treated with 27mg of pegozafermin given weekly compared to placebo after 8 weeks (62% vs. 51%, for patients not on background therapy; p=0.013, and 68% vs. 59% for patients on background therapy; p= 0.012).

Significant reductions in TGs were observed consistently across all prespecified patient subgroups. The trial also met numerous secondary endpoints, including improvements in atherogenic lipoproteins, metabolic measures and liver fat. Approximately 50% of patients in ENTRIGUE were on concomitant lipid-modifying therapy, which is representative of the real-world setting.

Pegozafermin was generally safe and well-tolerated. Of the 85 ENTRIGUE study participants randomized and treated with pegozafermin or placebo, 55% were on background lipid-modifying therapy (45% on statin therapy of which 55% were on high intensity statins, 14% on prescription fish oil, and 7% on fibrates). Results of the post hoc analysis of lipid effects of pegozafermin among study participants based on their lipid-modifying background therapy status demonstrated that pegozafermin significantly reduced TG and other atherogenic lipids after eight weeks of therapy.

Pegozafermin also led to reductions in TGs among patients on background high-intensity statins compared with placebo. pegozafermin-treated patients reached their initial treatment goal (i.e., a reduction in their TG level to less than 500 mg/dL) irrespective of background therapy. In the overall study population, 80% of those treated with pegozafermin reached their initial treatment goal compared with 29% of those on placebo (pAbout ENTRIGUE The randomized, double-blind, placebo-controlled ENTRIGUE trial enrolled 85 patients with SHTG either on stable background therapy or not on any background therapy who were treated weekly or every two weeks with pegozafermin.

The trial enrolled an advanced population with a high risk of cardiovascular disease as evidenced by mean baseline values of TGs of 733 mg/dL and non-HDL-C of 211 mg/dL; 43.5% had HbA1c =6.5%, and, in the subgroup of patients undergoing MRI-PDFF, liver fat content was 20.1%.