SAN FRANCISCO, March 20, 2021 (GLOBE NEWSWIRE) – 89bio, Inc. (Nasdaq: ETNB), a clinical-grade biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today. he cited additional positive data from his Phase 1b / 2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). The data will be presented in an on-demand poster display at ENDO 2021, the annual meeting of the Endocrine Society taking place almost from March 20-23, 2021.
“Excess liver fat is an important cause of disease progression for people living with NASH and can be associated with an increased risk for cardiovascular events and even death,” said Hank Mansbach, 89bio’s chief medical officer. “We are encouraged by new analyzes from our Phase 1b / 2a study that show that BIO89-100 showed clinically significant reductions in liver fat volume and overall liver size across all dosing groups. The data continue to highlight the promising clinical image of BIO89-100 and support further development of BIO89-100 in NASH and also true hypertriglyceridemia. ”
New studies of Phase 1b / 2a study data showed that BIO89-100 treatment resulted in significant reductions in liver volume up to 15% and liver fat volume up to 65% in patients treated at 13 weeks compared to a. baseline, as measured by magnetic. fat fraction proton-density imaging (MRI-PDFF). These data extend the previously reported MRI-PDFF data in which BIO89-100 treatment yielded up to 70% a relative reduction in liver fat fraction compared with placebo treatment. In addition, BIO89-100, as previously reported, showed a favorable safety and tolerability profile, with levels of gastrointestinal side effects such as nausea, diarrhea and placebo-like vomiting.
Details of the poster display are as follows:
Session: P02 – Integrated Psychology of Obesity and Metabolic Disease
Poster Display: # 53
Poster Title: BIO89-100 Strong Decreases in Fat and Liver Disease (LFV) with MRI-PDFF, Favorable Tolerability and Ability to Weekly (QW) or Every 2 Weekly (Q2W) Shedding in a placebo-controlled phase 1b / 2a. , A double-dose, multi-concentration study in NASH
Author in attendance: Juan Pablo Frias, MD
A copy of the poster display is also available on the 89bio website.
NASH is the most advanced stage of non-alcoholic fatty liver disease (NAFLD). It is a complex metabolic disorder that causes fat buildup in the liver, as well as inflammation and eventually fibrosis, and can progress to cirrhosis and liver failure. NASH affects more than 16 million adults in the United States, and by 2030 its frequency is expected to rise 63 percent. The exact cause of NASH is not known, but it is commonly found in people with type 2 obesity and diabetes. Although treatments are not currently approved, the biopharmaceutical industry is actively involved in addressing the unmet medical need.
About Stage 1b / 2a Inspection
This clinical study was a multifactorial, randomized, double-blind, placebo-controlled, multivariate, controlled trial. It was designed to evaluate the safety, tolerability, and PK properties of BIO89-100 as well as changes in liver fat measured by MRI-PDFF and key biomarker assessments in patients with NASH confirmed by biopsy with fibrosis or patients with phenotypical NASH (PNASH). PNASH has been defined as patients with steatosis greater than 10% with moderate obesity and Type 2 diabetes or moderate obesity and evidence of liver injury. All groups recorded at baseline had the same type of disease. A total of 81 patients were randomized to receive subcutaneous doses of BIO89-100 or placebo weekly or every two weeks for up to 12 weeks. Results analyzed across all dose groups from the trial contribute to a growing body of evidence demonstrating the promise of BIO89-100 for NASH treatment. Results showed strong reductions in liver fat and key liver markers. A strong efficacy profile and favorable tolerance were observed with weekly and bi-weekly doses.
BIO89-100 is a glycoPEGylated analog of FGF21 being developed for NASH treatment. 89bio has engineered BIO89-100 using proprietary glycoPEGylation technology to balance efficiency and longer dosing intervals. Recent Phase 1b / 2a data showed that BIO89-100 showed a favorable safety and tolerability profile and strong reductions in liver fat and key lipid markers when injected weekly (QW) or once every two weeks. week (Q2W). BIO89-100 is also being developed for the treatment of severe hypertriglyceridemia (SHTG) and is currently in a Phase 2 trial.
89bio is a clinical-grade biopharmaceutical company with a focus on the development and commercialization of innovative medicines for the treatment of liver and cardio-metabolic diseases. The company’s main product candidate, BIO89-100, is a glycoPEGylated analog with a specific engine of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with activity in Herzliya, Israel.
Contact an investor:
Chief Financial Officer
Contact the media: