Galecto Inc (NASDAQ: GLTO) has enrolled patients for the second and third parts of its Phase Ib/IIa GB1211, GULLIVER-2 study. The company is investigating GB1211 as a potential therapy for liver cirrhosis. This disease has limited treatment options. It develops progressively, eventually causing liver failure.
GULLIVER-2 is the trial of GB1211 that will look into the pharmacokinetics, tolerability, and safety is the compound. It also includes a Phase II study to test for safety and show the drug’s effect on coagulation, fibrosis, inflammation, and hepatic function. This study design is to examine GB1211 from different angles and determine whether it is an option for patients with liver cirrhosis.
Parts of the study
The GULLIVER-2 study has three parts. The first part measured the drug’s pharmacokinetics in people with moderate liver impairment. Researchers then compared these results with people who had healthy livers. Galecto completed this study in 2021 and found that GB1211 did not produce any significant adverse effects.
The second part of the study is a placebo-controlled, double-blind, and randomized study. For this study, the researchers will use 30 patients with moderate liver impairment and liver cirrhosis. The trial takes up to 12 weeks and examines the tolerability and safety of GB1211.
Part 2 also measures coagulation, inflammation, hepatic function, and fibrosis biomarkers. The third part of the stud, on the other hand, monitors 6sixpatients with advanced liver impairment. Researchers will then compare the effect of GB1211 on these patients to 6 others who are healthy.
Galectin-3 is involved in liver cirrhosis
According to Galecto’s CEO and President, Hans Schambye, M.D., the company is excited to have completed the first part of its study. He explains that GB1211 is a galectin-3 inhibitor.
Galectin-3 is an integral part of liver cirrhosis as it causes the development of fibrosis in the liver. The levels of Galectin-3 in people with liver cirrhosis are often high. Moreover, its high levels are a part of the prognosis for hepatocellular carcinoma
The company’s researchers have found that GB1211 effectively protects the livers of animal models from fibrosis. Galecto hopes to have its results for the trial in Q4 2022.