Galectin Therapeutics to Share Five Scientific Presentations at The Liver Meeting™ 2022, Hosted by the AASLD

• Prevalence of esophageal and gastric varices in patients with compensated NASH cirrhosis and portal hypertension
• Biochemical and imaging profiles in 271 patients with compensated NASH cirrhosis and portal hypertension
• Hepatic Expression of Galectin-3, a Pro-fibrotic and Pro-inflammatory Marker
• Clinical utility of the ELF score in compensated NASH cirrhotic patients with portal hypertension
• Histological correlation with portal pressures and varices in NASH cirrhosis using quantitative digital pathology

NORCROSS, Ga., Nov. 01, 2022 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3, today announced that it will share five scientific presentations at The Liver Meeting™ 2022, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held November 4-8, 2022, in Washington, D.C.

“For the sake of our patients, we need to bring more attention to liver cirrhosis and, particularly, to portal hypertension, a clinically relevant complication of the disease for which no etiologic treatment exists,” said Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. “ Early therapeutic intervention to counteract the process of portal hypertension increases the chance of success, and this is exactly what we are trying to do with our candidate drug Belapectin, a galectin-3 inhibitor. This year at AASLD Liver Meeting, we will share more information on the patient population we are recruiting for our global NAVIGATE phase 2b/3 study; our adjudication process for esophago-gastric endoscopies, an essential element in our objective to demonstrate that belapectin can prevent the development of esophageal varices; and the mechanism of action of the drug. We are also happy to share with the medical community new data regarding a non-invasive test (NIT) and liver histology reading with artificial intelligence (AI) in patients affected by NASH cirrhosis and portal hypertension.”

Abstracts will be available for viewing by attendees on the AASLD website and are also featured in the October supplement to the AASLD journal, Hepatology.

Presentation Details

Title: Prevalence of esophageal and gastric varices in patients with compensated non-alcoholic steatohepatitis (NASH) cirrhosis and portal hypertension. Data from the NAVIGATE study

Abstract Number: 2329
Authors: Boudes Pol, Alkhouri Naim, Ladron de Guevara Cetina Laura, Elgouhari Hesham, Mena Edward, Ortiz-Lasanta Grisell, Lawitz Eric, Moore Ann, Borg Brian, Noureddin Mazen, Lucas Kathryn, Vuppalanchi Raj, Reiss Gary, Schiefke Ingolf, Safadi Rifat, Shiffman Mitchell, Behari Jaideep, Patel Chirag, Ben-Ari Ziv, Halegoua-De Marzio Dina, Patel Pankaj, Patel Bhaktasharan, Caldwell Stephen, Ghalib Reem, Kayali Zeid, Vierling John, Williams Alonzo, Aazami Hessam, and Mills-Wilson Marla, for the NAVIGATE study group.
Date: Saturday, November 5, 2022
Time: 1:00 pm – 2:00 pm ET

Title: Biochemical and imaging profiles in 271 patients with compensated NASH cirrhosis and clinically suspected portal hypertension: an ongoing prospective cohort

Abstract Number: 2337
Authors: Boudes P, Alkhouri N, Elgouhari H, Lucas K, Lawitz E, Borg B, Vuppalanchi R, Behari J, Patel C, Noureddin M, Reiss G, Halegoua-De Marzio D, Caldwell S, Ghalib R, Landaverde C, Patel P, Shiffman M, Moore A, Kopaczewski J, Mills-Wilson M, for the NAVIGATE study group
Date: Saturday, November 5, 2022
Time: 1:00 pm – 2:00 pm ET

Title: Hepatic Expression of Galectin-3, a Pro-fibrotic and Pro-inflammatory Marker – An Immunohistochemical Survey

Publication Number: 1407
Authors: Zachary D. Goodman, MD, PhD; Ezra Lowe, PhD; Pol F. Boudes, MD, Inova Health System, Fall Church, VA, USA, Galectin Therapeutics, Norcross, GA, USA
Date: Friday, November 4, 2022
Time: 12:00 pm – 1:00 pm ET

Title: Clinical utility of the ELF score in compensated NASH cirrhotic patients with portal hypertension

Publication Number: 2319
Authors: Boudes PF, Lowe E, Galectin Therapeutics
Date: Saturday, November 5, 2022
Time: 1:00 pm – 2:00 pm ET

Title: Histological correlation with portal pressures and varices in NASH cirrhosis using quantitative digital pathology

Publication Number: 36696
Authors: Mazen Noureddin, Dean Tai, Elaine L. K. Chng, Yayun Ren, Pol Boudes, Harold Shlevin, Stephen A. Harrison, Naga P. Chalasani, Zachary Goodman
Date: Available as ePoster

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis,” began enrolling patients in June 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About the American Association for the Study of Liver Diseases (AASLD)

AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. It also advances the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies. AASLD’s annual scientific conference, The Liver Meeting™, is the world’s premier meeting on liver disease, bringing together clinicians, associates, and scientists from around the world to exchange information on the latest research, discuss new developments in liver treatment and transplantation, and network with leading experts in the field of hepatology.

About Galectin Therapeutics

Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration for NASH with advanced fibrosis. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH-related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of combination immunotherapy for advanced melanoma and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies as modified to meet the requirements of the FDA may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. Global factors such as coronavirus may continue to impact NASH patient populations around the globe and slow trial enrollment and prolong the duration of the trial and significantly impact associated costs. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Company Contact:

Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com 

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor GR-MD-02.

Source: Galectin Therapeutics Inc.