89bio presents new analysis of data from Phase 2 ENTRIGUE trial of pegozafermin

89bio announced the presentation of additional data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia at the American College of Cardiology’s 72nd Annual Scientific Session & Expo Together with World Congress of Cardiology. 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 status. 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. 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. 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. As previously reported, pegozafermin-treated patients reached their initial treatment goal 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. Among those on lipid-modifying background therapy, the comparable figures were 85% and 46%, respectively; among those not on background therapy, the comparable figures were 73% and 0%, respectively. Treatment with pegozafermin also led to improvements in non-HDL cholesterol irrespective of background therapy; however, among study participants on background therapy those decreases were more robust. Improvements in apolipoprotein B, a key marker of cardiovascular risk and a direct measure of the number of atherogenic particles, were observed irrespective of background therapy, and there were no significant changes in levels of LDL-cholesterol across the participants.