89bio Announces Presentations of BIO89-100 Data at The Liver Meeting® 2019
SAN FRANCISCO and HERZLIYA, Israel, Nov. 11, 2019 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced that two posters related to its investigational therapy, BIO89-100, will be presented today at The Liver Meeting 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 8-12, in Boston, Massachusetts. BIO89-100 is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) in clinical development for the treatment of nonalcoholic steatohepatitis (NASH).
The poster presentations will include results from the Phase 1a clinical trial in healthy volunteers demonstrating that BIO89-100 was generally well tolerated at single doses up to 78 mg with a generally dose-proportional pharmacokinetic profile allowing for a weekly or every two-week dosing. BIO89-100 also was associated with robust and clinically significant improvements versus baseline in triglycerides, LDL-C, HDL-C and adiponectin in this study. A second poster presentation of preclinical data demonstrated the positive effect of BIO89-100 in reducing preference for sweetened water in obese monkeys will also be presented.
Abstract Number: 2138 Presentation Title: BIO89-100, a Novel GlycoPEGylated FGF21 Analogue Demonstrates Robust Reduction in Serum Lipids and Long Half-Life in a Phase 1 Randomized, Controlled Single Ascending Dose Trial in Healthy Subjects Session Title: NAFLD and NASH Therapeutics: Pharmacologic and Other Presenting Author: Dr. Rohit Loomba, Director, NAFLD Research Center, Professor of Medicine, University of California at San Diego Session Time: Monday, Nov 11 at 8 AM Location: Hynes Convention Center, Hall B
Abstract Number: 2173 Presentation Title: Weekly Subcutaneous Administration of BIO89-100, a Novel GlycoPEGylated-Fibroblast Growth Factor21 (FGF21) Analogue, Inhibits Sweetness Preference in Obese Cynomolgus MonkeysSession Title: NAFLD and NASH: Basic Presenting Author: Moti Rosenstock, Head of Preclinical Development, 89bio Session Time: Monday, Nov 11 at 8 AM Location: Hynes Convention Center, Hall B
About BIO89-100 BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and a trial is planned for evaluating its role in the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineered BIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies, BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio’s Phase 1a clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics. BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company’s animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluating BIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway. About 89bio 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.
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