Galecto Presents Positive Clinical Data at AASLD Showing Statistically Significant Improvements in Important Liver Parameters in Decompensated Cirrhosis Patients Statistically significant reductions observed in ALT, AST and GGT, supporting further development of GB1211 in severe liver diseases Findings to be discussed in a conference call and virtual webinar today, November 8, 2022, at 8 a.m. ET
BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and a world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, announced it will discuss topline data and additional analyses from its recently completed Phase 1b/2a GULLIVER-2 trial (NCT05009680), including the observed statistically significant signs of liver protection, in a conference call and virtual webinar today, Tuesday, November 8th at 8:00 a.m. ET. The study was selected for a late-breaking oral presentation at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2022. Topline data showed statistically significant reductions in the liver enzymes ALT (p
Dr. Michael Charlton, Professor of Medicine and Chief of Hepatology at the University of Chicago, commented, “This is the first study in a population of Child-Pugh Class B decompensated cirrhosis patients of non-viral etiology showing changes in a series of liver parameters that are potentially clinically meaningful. The values of several of these parameters improved further over time and were linked to a reduction in galectin-3, demonstrating target engagement. These results, coupled with a favorable tolerability profile, provide additional evidence that GB1211 merits further investigation and may offer a tolerable intervention in liver diseases.” Liver enzyme (AST, ALT, and GGT) reductions were observed after seven days of treatment and continued to decrease over the 12 weeks of treatment. 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. The use of GB1211 in the GULLIVER-2 trial showed encouraging numerical improvements in liver health biomarkers after 12 weeks of therapy. GB1211 exhibited a favorable tolerability profile in Child-Pugh B decompensated liver cirrhosis patients. Five of 15 patients on GB1211 and four of 15 patients on placebo reported nine and eight treatment-emergent adverse events (TEAEs), respectively. Three serious TEAEs were observed in one patient on GB1211, but were deemed to be unrelated to GB1211. “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 T. Schambye, M.D., Ph.D. “Despite the substantial health burden that liver disease poses, scientific advances in therapeutics have been disappointing. There remains a significant need for disease modifying therapies that postpone or replace liver transplantation in late-stage liver cirrhosis patients. With these promising data in hand, we plan to conduct future studies that will explore the use of GB1211 in patients with liver disease.” GULLIVER-2 Topline Data Webcast Information:
Galecto will host a live conference call and webcast at 8:00 am ET on Tuesday, November 8, 2022. U.S. Dial-in Number:1-877-300-8521Int’l Dial-in Number:1-412-317-6026Conference ID:10172584Webcast:Click HERE
The presentation and poster materials along with a replay of the call will be available on Galecto’s investor relation’s website at https://ir.galecto.com. 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). 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 on a wide series of markers of hepatic function and structure 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. Primary endpoints were safety and PK of GB1211. Secondary endpoints included assessment of GB1211 effect on liver clinical laboratory parameters, liver stiffness, and liver fat content, as measured by vibration controlled transient elastography (VCTE), and assessment of the model for end-stage liver disease (MELD) scores. 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. 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 intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking Statements
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, that GB1211 may offer a tolerable intervention in moderate and severe liver diseases, 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to whether preliminary data that is reported herein changes following a more comprehensive review, the ongoing development of Galecto’s product candidates and evaluation of their therapeutic potential, including emerging data on the safety profile of such candidates and their potential for disease-modifying activity, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on February 17, 2022. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. For more information, contact:
Jon Freve, CFO +45 70 70 52 10
Media/EUAshley R. Robinson
arr@lifesciadvisors.comSandya von der Weid
svonderweid@lifesciadvisors.com+1 617 430 7577