Galecto Announces First Patient Treated in Phase 2 Trial of Oral Galectin-3 Inhibitor GB1211 in Liver Cirrhosis
BOSTON, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a publicly listed company focused on the development of novel treatments for fibrosis and cancer, today announced that the first patient has been treated with the galectin-3 inhibitor GB1211 in the Phase 1b/2a GULLIVER-2 trial. This trial marks the initiation of Galecto’s clinical program for GB1211 in liver cirrhosis. Top line data from the full trial is expected in the second half of 2022.
“We are very pleased with the continued momentum of our clinical programs and the start of this important study in liver cirrhosis,” said Dr. Hans Schambye, CEO of Galecto. “The initiation of this trial follows our strategy of targeting indications with high unmet medical need based on solid biological evidence. Galecto now has three different drug candidates in three phase 2 clinical trials, highlighting the breadth of our product portfolio, and we plan to initiate a second Phase 2 trial of GB1211 in combination with a PD-1/-L1 checkpoint inhibitor for the treatment of non-small-cell lung cancer (NSCLC) during the first half of 2022.”
The GULLIVER-2 trial (NCT05009680) will assess the safety, tolerability, pharmacokinetics and efficacy of GB1211 in up to 54 participants, including liver cirrhosis patients with moderate or severe hepatic impairment (Child Pugh classes B and C). The trial will randomize liver cirrhosis patients of any etiology and evaluate the impact of GB1211 on liver fibrosis and liver function.
Galectin-3 plays a key role in fibrosis development through cellular activation and the production of collagen, and Galecto has demonstrated that inhibiting the galectin-3 target with GB1211 reduces fibrosis in multiple animal models. Galectin-3 is elevated in cirrhosis patients and is a prognostic biomarker of hepatocellular carcinoma, a known complication of liver cirrhosis.
It is estimated that more than 100 million patients suffer from liver cirrhosis worldwide and the mortality rate is high. There are no approved disease modifying therapies and liver transplantation remains the sole option for late stage liver cirrhosis.
GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and had dose-dependent pharmacokinetics.
About Galectin-3 in Liver Cirrhosis
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