Pharmacokinetics and safety of belapectin in patients with hepatic insufficiency
Lack of impact of belapectin on cardiac repolarization (QT interval)
Very High Elevation of Gamma-Glutamyl Transpeptidase (GGT) as a new marker of disease progression in patient with portal hypertension and liver cirrhosis
Clinical significance and interpretation of serum galectin-3 levels in patients with advanced liver disease
Impact of obesity and muscle wasting to evaluate renal function in patients with portal hypertension and NASH cirrhosis
NORCROSS, Ga., Nov. 03, 2023 (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™ 2023, hosted by the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting™ will be held November 10-14, 2023, in Boston, Mass.
“This year again we are happy to share some of the progress we have made in our global program with belapectin, our galectin-3 inhibitor. We are also proud to bring additional knowledge to the field regarding liver cirrhosis, a disease that dramatically affects the lives of our patients and has been neglected for far too long,” said Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. “In liver cirrhosis, the early recognition of portal hypertension is essential to address the cirrhotic disease process at a stage when it is still potentially reversible, before the time liver transplant becomes the only curative option. We will share more information on the safety profile of belapectin and the fact that its pharmacokinetics properties are not affected by the degree of liver impairment.”
Dr. Boudes continued: “Contrary to most drugs that need to be metabolized by hepatocytes, we think that the unique and advantageous characteristics of belapectin are explained by its carbohydrate composition and its preferential distribution to intra-hepatic activated macrophages, the very cells that produce galectin-3. We link these characteristics to the apparent good tolerance and safety profile of belapectin highlighted during the recent, fourth independent Data and Safety Monitoring Board review of our global pivotal study NAVIGATE.”
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.
Title: "Pharmacokinetics And Safety Of Belapectin, A Candidate Drug For Nash Cirrhosis, In Subjects With Normal Hepatic Function And Subjects With Varying Degrees Of Hepatic Impairment"
Abstract Number: 3130-A
Authors: Ezra Lowe1, Steven Schoenfeld1, Eric Lawitz2, Stephen Harrison3, Zeid Kayali4 and Pol Boudes1
1 Galectin Therapeutics, Norcross, GA; 2 Texas Liver Institute, San Antonio, TX; 3 Pinnacle Research, San Antonio, TX; 4 Inland Empire Liver Foundation, Rialto, CA
Date, time, location: Sunday, November 12, 2023: 8:00 AM - 5:00 PM, Hynes Convention Center, Poster Hall A
Title: “ECG QT Interval Changes In Compensated Nash Liver Cirrhosis With Portal Hypertension. Experience With Belapectin, A Galectin-3 Inhibitor”
Abstract Number: 2450-C
Authors: Pol Boudes1, Steven Schoenfeld1, Ezra Lowe1
1 Galectin Therapeutics, Norcross, GA
Date, time location: Saturday, November 11, 2023: 8:00 AM - 5:00 PM, Hynes Convention Center, Poster Hall C
Title: “Very High Elevation Of Gamma-Glutamyl Transpeptidase In Nash Cirrhosis. A New Prognosis Factor?”
Abstract Number: 2269-C
Authors: Pol Boudes1, Eric Lawitz2, Naga Chalasani3
1 Galectin Therapeutics, Norcross, GA 2 Texas Liver Institute, San Antonio, TX 3 Indiana University, Indianapolis, IN
Date, time, location: Saturday, November 11, 2023: 8:00 AM - 5:00 PM, Hynes Convention Center, Poster Hall C
Title: “Serum Galectin-3 In Portal Hypertension Due To Nonalcoholic Steatohepatitis (Nash)”
Abstract Number: 2103-A
Authors: Pol Boudes1, Ezra Lowe1, Michael Inkmann1, Steven Schoenfeld1
1 Galectin Therapeutics, Norcross, GA. USA
Date, time, location: Saturday, November 11, 2023: 8:00 AM - 5:00 PM, Hynes Convention Center, Poster Hall A
Title: “Impact Of Obesity And Sarcopenia When Estimating Glomerular Filtration Rate In Patients With Compensated Nash Cirrhosis And Portal Hypertension. A Need For Population-Specific And Race-Specific Validation”
Abstract Number: 3079-A
Authors: Pol Boudes1, Eric Lawitz2, Don Rockey3, Stephen A Harrison4, Naga Chalasani5
1 Galectin Therapeutics, Norcross, GA. USA 2 Texas Liver Institute, San Antonio, TX, USA 3 Medical University of South Carolina, Charleston, SC 4 Pinnacle Clinical Research, San Antonio, TX, USA 5 Indiana University School of Medicine, Indianapolis, IN, USA
Date, time, location: Sunday, November 12, 2023: 8:00 AM - 5:00 PM, Hynes Convention Center, Poster Hall A
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH/MASH 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,” is fully enrolled, and further details are 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 liver cirrhosis due to NASH/MASH and portal hypertension
Non-alcoholic steatohepatitis (NASH), also known as MASH, has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. Liver cirrhosis is further complicated by portal hypertension which is one of the main mechanism leading to decompensated liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH/MASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver cirrhosis.
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 () is a carbohydrate-based drug that inhibits galectin-3, a protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases processes. Belapectin received a Fast Track designation by the U.S. Food and Drug Administration. The lead development program is liver cirrhosis caused by non-alcoholic steatohepatitis (NASH), also known as Metabolic dysfunction-Associated SteatoHepatitis (MASH), the most advanced form of NASH/MASH-related fibrosis.. An additional development program of belapectin is in combination with immunotherapy (checkpoint inhibitors) for advanced Head and Neck cancers. Advancement of this additional clinical programs is largely dependent on additional financing and/or 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, findings of safety of a drug candidate are not indicative of the drug candidate’s efficacy; 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 further 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, 2022, 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.
Jack Callicutt, Chief Financial Officer
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 belapectin (GR-MD-02).