Galecto to Present Topline Data from GULLIVER-2 Clinical Trial Showing GB1211 Reduced Signs of Liver Impairment at AASLD’s The Liver Meeting® 2022
- Late-breaking oral and poster presentations include clinical and preclinical data related to GULLIVER-2 clinical trial
Galectoto host a webinar at 8:00 a.m. ETon Tuesday, November 8, 2022to discuss expanded topline data and analysis
In a late-breaking oral presentation, which was selected as Best of the Liver Meeting in the NASH/NAFLD category,
Additional information and further analysis of these data relating to the GULLIVER-2 Part 2 trial findings will also be discussed in a webinar hosted by
In a separate poster presentation,
In support of the clinical data to be presented at The Liver Meeting 2022,
“With no approved disease-modifying treatments for decompensated cirrhosis, overall survival rates are poor with a median survival of approximately two years,” said
|Oral Presentation Title:||Preliminary safety, pharmacokinetics, and efficacy of GB1211 in cirrhotic patients: initial findings from the GULLIVER-2 trial with focus on the randomized, placebo controlled, 12-week part 2|
|Poster Presentation Title:||The novel GALECTIN-3 inhibitor GB1211 reduces inflammation & fibrosis in a rabbit high fat diet model of NASH & fibrosis|
|Poster Presentation Title:||GULLIVER-2 is an innovative, hybrid, hepatic impairment trial of the oral GALECTIN-3 inhibitor GB1211|
The abstracts for each of these presentations may be accessed here.
GULLIVER-2 Topline Data Webcast Information:
|Int’l Dial-in Number:||1-412-317-6026|
The presentation and poster materials along with a replay of the call will be available on Galecto’s investor relations website at https://ir.galecto.com.
About Liver Disease
Liver diseases, including liver fibrosis or cirrhosis, are a global health burden. Cirrhosis – primarily caused by non-alcoholic steatohepatitis, alcoholic liver disease and hepatitis – is the end stage of progressive liver fibrosis and the leading cause of liver-related death globally.
About the GULLIVER-2 Trial
The GULLIVER-2 trial (NCT05009680) is a Phase 1b/2a trial designed to assess the safety, tolerability, pharmacokinetics and potential activity of GB1211 in up to 54 participants. This study includes patients with decompensated cirrhosis (Child-Pugh Classes B and C). The study consists of three separate parts.
Parts 1 and 3 of the GULLIVER-2 trial are open-label, single dose study parts designed to evaluate the safety and pharmacokinetics of GB1211 in patients with moderate to severe hepatic impairment (Child-Pugh B and C, respectively) and compare with matched healthy subjects.
Part 2 of the GULLIVER-2 trial is a Phase 2, randomized, double-blind, placebo-controlled trial in 30 patients that is designed to assess the effect of 12-week repeated dosing of oral GB1211 in patients with decompensated cirrhosis (Child-Pugh B). Patients are randomized 1:1 to receive oral GB1211 100mg or placebo twice daily for 12 weeks.
Galecto is developing GB1211, an orally available and potent small molecule galectin-3 inhibitor. Galecto’s initial target indications for GB1211 are liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure, and non-small cell lung cancer, a cancer indication with a high unmet medical need.
GB1211 demonstrated antifibrotic activity and anti-cancer effects in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 had a favorable tolerability profile and exhibited dose-dependent pharmacokinetics.
Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has four ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in a separate Phase 2 trial for the treatment of non-small cell lung cancer (NSCLC) in combination with atezolizumab (Tecentriq®).
Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the tolerability and efficacy of GB1211, that the GULLIVER-2 trial will provide a holistic view of the safety, pharmacokinetics, liver function and liver-related parameters of GB1211, as well as Galecto’s general focus, plans for clinical development, product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements,
For more information, contact:
Hans Schambye, CEO
+45 70 70 52 10
+1 617 430 7577
+41 78 680 053
Source: Galecto, Inc.