Benzinga | Sep 3, 2020 08:30AM EDT

89bio Initiates Phase 2 Trial Of BIO89-100 On Patients With Severe Hypertriglyceridemia

- Multi-center, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BIO89-100 administered weekly or every two weeks for 8 weeks -

SAN FRANCISCO, Sept. 03, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced the initiation of a Phase 2 trial evaluating its product candidate BIO89-100 in patients with severe hypertriglyceridemia ("SHTG"). BIO89-100 is a glycoPEGylated analog of fibroblast growth factor 21 ("FGF21") in clinical development for the treatment of nonalcoholic steatohepatitis ("NASH") and SHTG.

"This new program builds on our strategy to leverage the biology of FGF21 to bring meaningful benefit to patients across a range of serious diseases with high unmet needs," said Hank Mansbach, Chief Medical Officer of 89bio. "Existing therapies for SHTG do not address the range of metabolic issues faced by these patients, that result in the increased risk of cardiovascular events and NASH. Our early clinical data indicate that BIO89-100 could offer robust and durable reductions in triglycerides as well as deliver broad metabolic benefits. This suggests BIO89-100 has the potential to be a highly differentiated new therapy for this condition."

The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy, and tolerability of BIO89-100 in patients with SHTG. The study will enroll approximately 90 patients who will be treated with BIO89-100 in one of four treatment groups or placebo administered in either weekly or every two weeks doses for a period of 8 weeks. The primary endpoint is the reduction in fasting triglycerides from baseline. Key secondary endpoints include the effect of BIO89-100 on other lipids and metabolic markers and change in liver fat measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Patients who meet screening criteria will undergo a lifestyle stabilization and triglyceride qualification period prior to randomization and will receive lifestyle counseling during the study.