Galecto Announces Preliminary Results For Oral Galectin-3 Inhibitor GB1211 In Part 1 Of Its Phase 1b/2a Liver Cirrhosis Trial; Says ‘GB1211 observed to be safe and well tolerated in initial twelve randomized subjects’

GB1211 observed to be safe and well tolerated in initial twelve randomized subjects, including six hepatically impaired liver cirrhosis patients
 

Galecto initiates Part 2 of Phase 1b/2a trial in patients with

GB1211 observed to be safe and well tolerated in initial twelve randomized subjects, including six hepatically impaired liver cirrhosis patients
 

Galecto initiates Part 2 of Phase 1b/2a trial in patients with liver cirrhosis

BOSTON, Dec. 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 it has successfully completed Part 1 of its Phase 1b/2a GULLIVER-2 trial, assessing the safety, tolerability and pharmacokinetics of the oral galectin-3 inhibitor GB1211 in patients with moderate hepatic impairment (Child-Pugh class B) as compared to healthy volunteers. GB1211 was observed to be well-tolerated, there were no drug-related serious adverse events, and exposure was only moderately increased in the Child-Pugh class B patients. Accordingly, no dose adjustment is required for Part 2 of the trial in patients with moderate hepatic impairment.

Galecto has also initiated Part 2 of the trial, which is a randomized, double-blind placebo-controlled trial designed to assess the effect of 12-week dosing of GB1211 on a wide series of biological markers of hepatic function and structure in participants with moderate hepatic impairment. The Phase 1b/2a GULLIVER-2 trial is the first in Galecto's clinical program for GB1211 in liver cirrhosis. Liver cirrhosis represents a significant unmet medical need for which there is no currently approved disease modifying therapy.

"Completing Part 1 of the GULLIVER-2 trial and initiating upon Part 2 is an important step forward in our development of GB1211 for liver cirrhosis," said Dr. Hans Schambye, CEO of Galecto. "We are very encouraged by the initial safety findings and favorable interim exposure data seen in Part 1 of the trial. We look forward to completing Part 2 of the trial in 2022, where we hope to demonstrate biomarker and clinical activity of GB1211. We remain on track to report top line data from the full trial in the second half of 2022."

The GULLIVER-2 trial (NCT05009680) is designed to assess the safety, tolerability, pharmacokinetics and potential activity of GB1211 in up to 54 participants, including liver cirrhosis patients with moderate or severe hepatic impairment (Child-Pugh classes B and C). In Part 2 of the trial, Child-Pugh class B liver cirrhosis patients of any etiology will be randomized to 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 including models of liver fibrosis. 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.