Galecto, Inc. announced it will present data from its recently completed Phase 1b/2a GULLIVER-2 trial at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting 2022 being held in Washington, D.C. on November 4-8, 2022. GULLIVER-2 is a clinical trial designed to assess GB1211, an orally available and high-affinity small molecule carbohydrate-based galectin-3 inhibitor, for the treatment of severe liver diseases. Galectin-3 is a pro-fibrotic ß-galactoside binding protein highly expressed in fibrotic livers and implicated in severe liver diseases.

In a late-breaking oral presentation, which was selected as Best of the Liver Meeting in the NASH/NAFLD category, Galecto will present topline data from Part 2 of its GULLIVER-2 trial (NCT05009680), an innovative, hybrid-design 3 part study investigating the safety, pharmacokinetics (PK), and exploratory efficacy of GB1211 in patients with decompensated cirrhosis. In this study, GB1211 was well-tolerated, had a predictable PK profile and showed encouraging signs of clinical efficacy (liver laboratory tests and FibroScan®). The observed reductions of liver enzyme values and measurements of liver fat indicate a decrease of liver inflammation and underlying steatosis, respectively.

Overall, the data suggests a positive therapeutic effect in severe cirrhosis. This trial offers strong support for further development of GB1211 in severe liver diseases. Additional information and further analysis of these data relating to the GULLIVER-2 Part 2 trial findings will also be discussed in a webinar hosted by Galecto on Monday, November 8th at 8 a.m. ET.

In a separate poster presentation, Galecto will highlight findings from Parts 1 and 3 of the GULLIVER-2 trial, where preliminary data indicates that liver impairment had moderate effects on the GB1211 PK profile compared to healthy participants. In patients with decompensated cirrhosis, GB1211 was observed to be well-tolerated with no treatment-related adverse events, supporting that it can be orally administered to patients with moderate and severe liver impairment in future trials. In support of the clinical data to be presented at The Liver Meeting 2022, Galecto will also present a late-breaking preclinical poster demonstrating GB1211's ability to inhibit galectin-3 in severe liver diseases.

In this study, the efficacy of GB1211 was investigated in a high fat diet rabbit model of non-alcoholic steatohepatitis (NASH)/fibrosis. GB1211 significantly reduced all measures of inflammation, fibrosis and fat compared to the control group. There were also trends for reduction in fibrotic and galectin-3 mechanistic genes (COL1A1, COL3A1, SNAI2, LGALS3, PAI-1), indicating positive effects of galectin-3 inhibition.