Galecto is trying to build out the case for its severe liver disease candidate GB1211, presenting phase 1/2 data linking the small-molecule inhibitor of galectin-3 to reductions in several enzymes in post hoc analyses.
The candidate is designed to reduce liver cell damage by inhibiting a target that is elevated in cirrhosis and toxic hepatitis. With Galecto pulling the plug on a study of GB1211 in nonalcoholic steatohepatitis last year because of the COVID-19 pandemic and a change in its clinical development strategy, the phase 1/2 GULLIVER-2 trial represents an early test of the theory that the drug can treat liver cirrhosis.
In part two of the trial, investigators randomized 30 people with moderately severe liver disease to take GB1211 or placebo for 12 weeks. Liver stiffness dropped 9.66 points in the GB1211 arm, versus a 7.62 fall in the placebo group. The proportion of patients with a 4kPa or greater reduction in liver stiffness was 77% in the GB1211 arm and 53% in the placebo group.
Liver stiffness is one of three secondary outcome measures listed on the ClinicalTrials.gov page for the study. The primary endpoints relate to safety and tolerability. Galecto’s statement lacks details of the results for the other secondary outcome measures, which looked at collagen production and break down biomarkers and changes in liver functional capacity.
Instead, the biotech focused on post hoc analyses of liver enzymes. The trial linked GB1211 to reductions in four liver enzymes of 14.8% to 58.4%. The 14.8% reduction in alkaline phosphatase fell short of statistical significance, but the declines in the other three liver enzymes met the threshold for success.
Galecto compared the results favorably to data from much larger studies of potential cirrhosis therapies selonsertib, emricasan, simtuzumab and belapectin, while noting that ”cross-trial comparisons cannot be made” because of differences between the programs.
Investors largely remain on the sidelines, bumping shares in the tiny biotech up 3% to $2.10 when the market opened, but Galecto has the time to win more people round. With its cash reserves set to last into the second half of 2024, the company has the money to deliver the four phase 2 readouts that are scheduled for next year.