89bio Reports Positive Topline Results from ENTRIGUE Phase 2 Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG)

– Trial met primary endpoint demonstrating statistically significant and clinically meaningful reductions across all doses (63% at the 27mg QW dose; p<0.001) in triglycerides (TG) from baseline; results were consistent in patients on or not on background therapy –

– Observed significant and potent reductions in atherogenic lipids (non-HDL-C and apo B), liver fat, and improvements in liver enzymes and glycemic control markers –

– ENTRIGUE results support 89bio’s transition to a late-stage development company; Phase 3 expected to initiate in first half of 2023 –

– Conference call and webcast today at 1:30 p.m. PST/4:30 p.m. EST –

Excerpt from the Press Release:

SAN FRANCISCO, June 28, 2022 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), today announced positive topline results from ENTRIGUE, the Phase 2 proof-of-concept study evaluating pegozafermin for the treatment of severe hypertriglyceridemia (SHTG). Treatment with pegozafermin resulted in clinically meaningful and significant reductions in triglycerides (TG) from baseline across all doses (with a 63% reduction in the highest dosing group; p<0.001) and various subgroups, statistically significant improvements in key markers of cardiovascular risk (non-HDL-C and apo B), reductions in liver fat, and improvements in glycemic control markers.

“There is a critical need for SHTG treatment options that not only reduce triglycerides but also address broader cardiometabolic risks including hepatic steatosis and improve insulin sensitivity” said Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center, Professor of Medicine, Harvard Medical School. “Treatment with pegozafermin demonstrated impressive triglyceride reduction coupled with meaningful reductions in non-HDL-C and improvements in cardiometabolic parameters. Taken together, pegozafermin’s profile in ENTRIGUE shows great potential to uniquely address the key needs for patients with SHTG.”

Results showed statistically significant reductions in median TGs from baseline across all dose groups treated with pegozafermin, compared to placebo after 8 weeks. Additionally, results were consistent in patients not on background therapy or on background therapy (consistent results on statins or statin combos, prescription fish oils, and fibrates) and across various subgroups, including those with the greatest disease burden, such as Type 2 diabetes and baseline TG levels ≥750 mg/dL.

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