Galecto ( NASDAQ: GLTO ) said its medicine GB1211 helped reduce certain liver enzymes in patients with decompensated cirrhosis in a phase 1b/2a trial.
The study, dubbed GULLIVER-2, evaluated GB1211 in up to 54 participants, which included patients with decompensated cirrhosis (Child-Pugh Classes B and C).
The company said that data showed reductions in liver enzymes ALT, AST and GGT after seven days of therapy and they continued to decrease over the 12 weeks of treatment. There were encouraging reductions for ALP after 12 weeks of treatment, according to Galecto.
High levels of these enzymes suggest liver disease.
The company added that these liver enzyme levels remained decreased compared to baseline two weeks after the study’s conclusion, suggesting durable effects and a decrease in liver inflammation.
GB1211 also showed improvement and consistent signs of activity across biochemical liver function markers and markers of target engagement, apoptosis (cell death), and fibrosis, including reductions in the protein galectin-3, according to the company.
Galecto said bilirubin, albumin, international normalized ratio (INR) and other biochemical measurements remained stable.
The company noted that the data suggests that GB1211 provided liver cell protection and improved liver status, further supporting clinical development in severe liver disease.
Galecto said 5 of 15 patients on GB1211 and 4 of 15 patients on placebo reported 9 and 8 treatment-emergent adverse events (TEAEs), respectively. Three serious TEAEs were seen in one patient on GB1211, but were deemed to be unrelated to GB1211, the company added.
"We have now reported data from three separate clinical trials in IPF, COVID-19 and liver cirrhosis showing the benefits of galectin-3 inhibition. The GULLIVER-2 topline results indicate promising signs of clinical activity, suggesting that GB1211 could be an excellent therapeutic candidate for patients with severe liver disease," said Galecto CEO Hans Schambye.
GLTO +12.44% to $2.26 premarket Nov. 8
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Galecto stock rises 12% as GB1211 shows efficacy in liver disease patients in trial