-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
▎WuXi AppTec Content Team Editor Recently, Galecto released the top-line data and additional analysis results of the clinical phase 1b/2a trial of its liver disease treatment drug GB1211, which significantly improved the level of a variety of liver enzymes and biomarkers related to the progression and prognosis of liver disease
。
Liver diseases, such as liver fibrosis or cirrhosis, are a global health burden
.
Cirrhosis is mainly caused by nonalcoholic steatohepatitis, alcoholic liver disease and hepatitis, which is an end-stage condition of progressive liver fibrosis and the leading cause of
liver-related death worldwide.
For liver disease, Galecto developed the drug GB1211, an oral small molecule galactoglutinin-3 inhibitor whose initial target indications were cirrhosis and non-small cell lung cancer
.
GB1211 has demonstrated antifibrotic activity and anticancer effects in multiple preclinical models and has successfully completed a Phase 1 trial
in 78 healthy volunteers.
In this trial, GB1211 was well tolerated and exhibited a dose-dependent pharmacokinetic profile
.
GULLIVER-2 is a Phase 1b/2a clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profile, and potential activity of GB1211 in a total of 54 participants
.
The study recruited patients with decompensated cirrhosis (Child-Pugh classes B and C).
The top-line data released this time showed that after 12 weeks of treatment, the levels of various liver enzymes showed a statistically significant decrease: ALT (p<0.
0005), AST (p<0.
005), GGT (p<0.
05), ALP (p<0.
09).
After treatment with GB1211, many indicators, such as biochemical liver function markers, target action markers, apoptosis and fibrosis markers, were significantly improved
.
In addition, bilirubin, albumin, international normalized ratio (INR), and other biochemical indicators remained stable
.
These data suggest that GB1211 treatment has a protective effect on liver cells and improves liver status, and these findings further support the development
of clinical drugs for severe liver disease.
Image source: 123RF
GB1211 therapy started quickly, with reductions in liver enzyme (AST, ALT, and GGT) levels observed after seven days of treatment and continued to decrease
over a 12-week treatment cycle.
Two weeks after the study, these liver enzyme levels still decreased compared to baseline, indicating that the treatment had a long-lasting effect and significantly reduced liver inflammation
.
GB1211 showed good tolerability
in patients with decompensated cirrhosis of Child-Pugh class B.
Five (5/15) in the GB1211 treatment group and four (4/15) in the placebo group reported 9 and 8 treatment-related adverse effects
, respectively.
A patient taking GB1211 had 3 serious adverse events, all of which were judged to be unrelated to
GB1211 treatment.
Preliminary results from the 123RF
GULLIVER-2 trial are consistent
with Galecto's previous findings on GB1211 。 In several preclinical models, inhibition of Galectin-3 resulted in a significant reduction in liver enzymes (ALT, AST and GGT), indicating that the drug has a positive effect on liver function and exerts a protective effect
on liver cells.
In addition, GB1211 reduced fibrosis in preclinical liver models, providing a preclinical proof
of concept for Galecto's treatment of severe liver disease.
There is also substantial evidence that high levels of galectin-3 are associated with
the severity of liver disease.
Because galectin-3 levels are elevated in decompensated cirrhosis and are a prognostic biomarker for hepatocellular carcinoma, Galecto believes that inhibition of galectin-3 holds promise for a viable treatment option
for severe liver disease.
Dr.
Hans T.
Schambye, CEO of Galecto, said in a press release, "We have now reported data from three separate clinical trials from a cohort of patients with idiopathic pulmonary fibrosis, COVID-19, and cirrhosis that demonstrate the clinical benefit
of galectin-3 inhibition 。 The top-line results of the GULLIVER-2 trial show promising clinical activity, indicating that GB1211 has the potential to be an excellent therapeutic candidate for patients with severe liver disease
.
Despite the enormous health burden caused by liver disease, scientific advances in related treatments have been disappointing
.
For patients with advanced cirrhosis, there is still an urgent need for disease-modifying therapies
that can delay or replace liver transplantation.
With these promising data, we plan to conduct future studies to explore the use of
GB1211 in patients with liver disease.
"
。
Liver diseases, such as liver fibrosis or cirrhosis, are a global health burden
.
Cirrhosis is mainly caused by nonalcoholic steatohepatitis, alcoholic liver disease and hepatitis, which is an end-stage condition of progressive liver fibrosis and the leading cause of
liver-related death worldwide.
For liver disease, Galecto developed the drug GB1211, an oral small molecule galactoglutinin-3 inhibitor whose initial target indications were cirrhosis and non-small cell lung cancer
.
GB1211 has demonstrated antifibrotic activity and anticancer effects in multiple preclinical models and has successfully completed a Phase 1 trial
in 78 healthy volunteers.
In this trial, GB1211 was well tolerated and exhibited a dose-dependent pharmacokinetic profile
.
GULLIVER-2 is a Phase 1b/2a clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profile, and potential activity of GB1211 in a total of 54 participants
.
The study recruited patients with decompensated cirrhosis (Child-Pugh classes B and C).
The top-line data released this time showed that after 12 weeks of treatment, the levels of various liver enzymes showed a statistically significant decrease: ALT (p<0.
0005), AST (p<0.
005), GGT (p<0.
05), ALP (p<0.
09).
After treatment with GB1211, many indicators, such as biochemical liver function markers, target action markers, apoptosis and fibrosis markers, were significantly improved
.
In addition, bilirubin, albumin, international normalized ratio (INR), and other biochemical indicators remained stable
.
These data suggest that GB1211 treatment has a protective effect on liver cells and improves liver status, and these findings further support the development
of clinical drugs for severe liver disease.
Image source: 123RF
GB1211 therapy started quickly, with reductions in liver enzyme (AST, ALT, and GGT) levels observed after seven days of treatment and continued to decrease
over a 12-week treatment cycle.
Two weeks after the study, these liver enzyme levels still decreased compared to baseline, indicating that the treatment had a long-lasting effect and significantly reduced liver inflammation
.
GB1211 showed good tolerability
in patients with decompensated cirrhosis of Child-Pugh class B.
Five (5/15) in the GB1211 treatment group and four (4/15) in the placebo group reported 9 and 8 treatment-related adverse effects
, respectively.
A patient taking GB1211 had 3 serious adverse events, all of which were judged to be unrelated to
GB1211 treatment.
Preliminary results from the 123RF
GULLIVER-2 trial are consistent
with Galecto's previous findings on GB1211 。 In several preclinical models, inhibition of Galectin-3 resulted in a significant reduction in liver enzymes (ALT, AST and GGT), indicating that the drug has a positive effect on liver function and exerts a protective effect
on liver cells.
In addition, GB1211 reduced fibrosis in preclinical liver models, providing a preclinical proof
of concept for Galecto's treatment of severe liver disease.
There is also substantial evidence that high levels of galectin-3 are associated with
the severity of liver disease.
Because galectin-3 levels are elevated in decompensated cirrhosis and are a prognostic biomarker for hepatocellular carcinoma, Galecto believes that inhibition of galectin-3 holds promise for a viable treatment option
for severe liver disease.
Dr.
Hans T.
Schambye, CEO of Galecto, said in a press release, "We have now reported data from three separate clinical trials from a cohort of patients with idiopathic pulmonary fibrosis, COVID-19, and cirrhosis that demonstrate the clinical benefit
of galectin-3 inhibition 。 The top-line results of the GULLIVER-2 trial show promising clinical activity, indicating that GB1211 has the potential to be an excellent therapeutic candidate for patients with severe liver disease
.
Despite the enormous health burden caused by liver disease, scientific advances in related treatments have been disappointing
.
For patients with advanced cirrhosis, there is still an urgent need for disease-modifying therapies
that can delay or replace liver transplantation.
With these promising data, we plan to conduct future studies to explore the use of
GB1211 in patients with liver disease.
"
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
.
If you have relevant business needs, please click the picture below to fill in the specific information
.
