89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company dedicated to developing and commercializing groundbreaking therapies for the treatment of liver and cardiometabolic diseases, is proud to announce the commencement of ENTRUST – a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG). A major milestone in the fight against SHTG, the study has the potential to provide groundbreaking options for better patient care.
Today marks an exciting moment for 89bio as the first FGF21 analog, pegozafermin, begins its Phase 3 development for the treatment of SHTG. Clinical results from our previous trials suggest a potentially favorable risk/benefit profile for pegozafermin, as demonstrated through robust reductions in triglycerides, broad metabolic improvements including reductions in liver fat, as well as favorable safety and tolerability.
We are thrilled to have the potential to optimize clinical advancement in non-alcoholic steatohepatitis (NASH) by leveraging the safety database from the SHTG Phase 3 program. Here at 89bio, we are excited to be a part of driving the progress of pegozafermin as it enters this important stage of its development.
The ENTRUST trial is a double-blind, placebo-controlled global study involving 360 genetically predisposed severe hypertriglyceridemia patients, divided into three equal groups. Each group will receive either a 30 mg or 20 mg subcutaneous injection of pegozafermin once weekly for 52 weeks, compared to a placebo group.
Primary endpoint of this trial is the percent change from baseline in fasting triglyceride levels at Week 26 with secondary endpoints such as liver fat assessment, non-HDL-C, HDL-C, apo-B, VLDL-C, HbA1c and total cholesterol levels. Join us in learning more about ENTRUST and sign up today to help us discover a potential breakthrough in genetic hypertriglyceridemia! For more information, please visit ClinicalTrials.gov (NCT05852431).
About severe hypertriglyceridemia (SHTG)
SHTG, an underappreciated condition affects up to four million people in the United States, is marked by extremely high triglyceride (TG) levels (>500mg/dL) posing increased risks for cardiovascular diseases and pancreatitis. People with this disorder also endure co-morbid metabolic disorders such as dyslipidemia, Type 2 diabetes and NAFLD.
Unfortunately, current treatments such as lifestyle changes and medications have modest effects on triglycerides levels. As a result, roughly 900,000 people in the US are unable to bring their TG levels down below the critical 500mg/dL threshold. This lead to a dire need for effective treatments to reduce TG levels and improve comorbidities in people with SHTG.
About pegozafermin
Pegozafermin, a specially engineered glycoPEGylated version of the natural hormone fibroblast growth factor 21 (FGF21), has the potential to revolutionize the way we treat non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
Research around FGF21 demonstrates its effectiveness in regulating energy expenditure, glucose, and lipid metabolism – providing a powerful target for reducing hepatic steatosis, lowering inflammation, and improving insulin resistance and glycemic control. This novel approach may open new doors in the treatment of NASH and SHTG.
About 89bio
89bio is a revolutionary biopharmaceutical company designed to help those suffering from liver and cardiometabolic diseases who lack adequate treatment options. With a singular priority to advance pegozafermin, their lead therapeutic candidate, through clinical development, 89bio is committed to providing the best-in-class solutions for those with non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). San Francisco is the proud home of 89bio, and their scientific pursuits continue to make a genuine difference in people’s lives.
Forward-Looking Statements
89bio’s forward-looking statements regarding its lead product candidate, pegozafermin, provide potential insight into its therapeutic benefits, efficacy, and clinical safety and tolerability profile, as well as its risk/benefit ratio. These statements also highlight 89bio’s clinical development plans, including the Phase 3 ENTRUST trial in SHTG, and the potential synergies to be derived from developing pegozafermin.
Although these expectations are reasonable, they are subject to risks and uncertainties, including 89bio’s ability to execute its strategy, potential competition from competing products, and FDA approval and feedback. Furthermore, the uncertain effects of the COVID-19 pandemic have added additional complexity to 89bio’s clinical trials and business operations. Therefore, investors should remain aware of the possibility of unexpected delays or other changes in plans.