89bio Inc.

Address: 655 Montgomery Street Floor 15th

Sponsor Overview

assignment

Specializations

Metabolic Liver Diseases

The sponsor concentrates its research efforts on addressing severe metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver condition characterized by inflammation and fibrosis. Their investigational approaches target patients with advanced hepatic fibrosis, particularly those at stages F2 and F3, representing significant disease burden and elevated risk of progression to cirrhosis. The research portfolio emphasizes therapeutic interventions designed to modify disease progression in patients with confirmed liver fat accumulation and metabolic dysfunction.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Advanced Hepatic Fibrosis Management
Liver Inflammation and Scarring

The therapeutic development strategy focuses on patients with documented histological evidence of disease, targeting populations with elevated liver enzyme levels and metabolic abnormalities that contribute to progressive liver damage.

Cardiovascular and Cardiometabolic Disease

A significant research focus addresses the intersection of metabolic and cardiovascular health, particularly in patients with severe hypertriglyceridemia (SHTG). The sponsor investigates therapeutic solutions for individuals with markedly elevated triglyceride levels, a condition associated with increased cardiovascular risk and potential complications including pancreatitis. Their clinical development programs target patients with persistent lipid abnormalities despite standard therapeutic interventions.

Severe Hypertriglyceridemia Treatment
Lipid Metabolism Disorders
Cardiovascular Risk Reduction

The research encompasses patients with fasting triglyceride concentrations substantially above normal ranges, focusing on populations at heightened risk for cardiovascular events and metabolic complications related to dyslipidemia.

Fibrotic Disease Modification

The sponsor pursues innovative approaches to hepatic fibrosis regression and prevention of disease progression in patients with chronic liver conditions. Their research programs investigate mechanisms to reduce collagen deposition and reverse scarring processes in the liver, targeting the underlying pathophysiology that drives progression from inflammation to cirrhosis. The therapeutic focus encompasses patients with biopsy-confirmed fibrosis stages requiring intervention to prevent advancement to end-stage liver disease.

Liver Fibrosis Reversal
Anti-Fibrotic Therapeutic Strategies
Prevention of Cirrhosis Progression

Clinical investigations emphasize measurable improvements in fibrosis staging and histological markers of disease severity, with particular attention to populations at risk for developing complications associated with advanced scarring.

Trial Name	Country	Status
Evaluation of Pegozafermin Efficacy and Safety in Patients with Metabolic Dysfunction-Associated Steatohepatitis and Fibrosis: A Phase 3 Clinical Trial	Austria Belgium Bulgaria Czechia France Germany Italy Poland Spain The Netherlands	Recruiting
Evaluation of Pegozafermin Efficacy and Safety in Severe Hypertriglyceridemia: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial	Austria Belgium Bulgaria Czechia France Germany Hungary Italy Latvia Poland Spain	Not Recruiting
Phase 3 Evaluation of Pegozafermin Efficacy and Safety in Metabolic Dysfunction-Associated Steatohepatitis with Compensated Cirrhosis	Belgium Bulgaria France Germany Hungary Italy Poland Spain The Netherlands	Recruiting