galectin 3 inhibitors / Galectin Therap - LARVOL DELTA

BELAPECTIN MAINTAINS A FAVORABLE TREND IN REDUCING VARICEAL DEVELOPMENT OVER 36 MONTHS IN MASH CIRRHOSIS: RESULTS: FROM THE NAVIGATE TRIAL (AASLD 2025) - P2/3 | "In MASH cirrhosis with portal hypertension, belapectin 2 mg/kg continued to show a favorable trend in reducing new varices through 36 months in the per-protocol population. These findings show a continuous and sustained effect thru 36 month and support the long-term potential of galectin-3 inhibition for variceal prevention in patients with MASH cirrhosis and portal hypertension."

Cardiovascular • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension • Type 2 Diabetes Mellitus

BELAPECTIN REDUCES LIVER STIFFNESS PROGRESSION AND PREVENTS VARICES AT 18 MONTHS IN MASH CIRRHOSIS: RESULTS: FROM THE NAVIGATE TRIAL (AASLD 2025) - P2/3 | "Belapectin, a galectin-3 inhibitor, is being evaluated in NAVIGATE (NCT04365868), a Phase 2b/3 randomized, placebo-controlled trial aimed at preventing variceal development in patients with compensated MASH cirrhosis and portal hypertension without baseline EV... Belapectin 2 mg/kg was associated with significantly less worsening of LSM at 18 months compared to placebo, using both ≥30% and ≥10 kPa thresholds. Furthermore, less worsening in LSM was linked to a lower incidence of new varices, reinforcing the clinical relevance of LSM progression as a surrogate marker. These findings suggest a potential beneficial effect of belapectin on disease progression in MASH cirrhosis and warrant further investigation in future studies."

Cardiovascular • Fibrosis • Gastroenterology • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension

Belapectin at 2 mg/kg/LBW reduces varices development in MASH cirrhosis with portal hypertension: results from the NAVIGATE trial (EASL 2025) - P2/3 | "Belapectin, a galectin-3 inhibitor, previously showed reduced hepatic venous pressure gradient (HVPG) and varices development in MASH cirrhosis without baseline varices (Chalasani et al., Gastroenterology 2020)... Belapectin at 2 mg/kg/LBW significantly reduced varices development in the PP population at 18 months, replicating prior Phase 2 findings. Long-term 36-month follow-up data will provide further insights. These results support continued investigation of belapectin in a Phase 3 trial for MASH cirrhosis with portal hypertension."

Late-breaking abstract • Cardiovascular • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension • Type 2 Diabetes Mellitus

BASELINE PATIENTS' CHARACTERISTICS FROM NAVIGATE, A SEAMLESS ADAPTIVE PHASE 2B/3 TRIAL OF BELAPECTIN IN MASH CIRRHOSIS AND PORTAL HYPERTENSION (AASLD 2024) - P2b | "Belapectin, a galectin-3 inhibitor, is being investigated in NAVAGATE (NCT04365868), an adaptive phase 2b/3 trial aimed at preventing the development of esophageal varices (EV) in patients with compensated cirrhosis with portal hypertension (PH)... The low MELD score and predominantly Child Pugh Class A5 population enrolled in the phase 2b stage of the trial constitutes a population that can be amenable to the stabilization or reversal of portal hypertension. The clinical translation of this effect will be reflected in the primary prevention of esophageal varices, hence the prevention of bleeding from these varices."

Clinical • P2/3 data • P2b data • Cardiovascular • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension • Thrombocytopenia

IN PATIENTS WITH COMPENSATED MASH CIRRHOSIS WITH PLATELET COUNT < 150,000/&MICRO; L AND RADIOLOGIC FINDINGS OF PORTAL HYPERTENSION, A THIRD ARE IDENTIFIED WITH ESOPHAGEAL VARICES ON SCREENING ESOPHAGO-GASTRODUODENOSCOPY (AASLD 2024) - P2b | "We present data from NAVIGATE, a phase 2b/3 trial designed to evaluate Belapectin, a galectin-3 inhibitor, for the primary prevention of esophageal varices (NCT04365868)... In this prospectively enrolled cohort of patients with compensated MASH cirrhosis with imaging findings of portal hypertension, platelet count below 150 x 103/µL was associated with EGD-determined esophageal varices in one third of patients."

Clinical • Cardiovascular • Fibrosis • Gastroenterology • Hematological Disorders • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Portal Hypertension • Thrombocytopenia

ECG QT INTERVAL CHANGES IN COMPENSATED NASH LIVER CIRRHOSIS WITH PORTAL HYPERTENSION. EXPERIENCE WITH BELAPECTIN, A GALECTIN-3 INHIBITOR (AASLD 2023) - "QT/QTc prolongation is frequent in compensated cirrhosis with portal hypertension but does not appear symptomatic. In this study belapectin did not appear to be associated with adverse events related to QTc prolongation. 1 Bernardi, et al."

Cardiovascular • Fibrosis • Gastroenterology • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis • Portal Hypertension

SERUM GALECTIN-3 IN PORTAL HYPERTENSION DUE TO NONALCOHOLIC STEATOHEPATITIS (NASH) (AASLD 2023) - P1, P2 | "Serum galectin-3 might not be a useful biomarker of disease activity in NASH, particularly in compensated cirrhosis with portal hypertension. As in the oncology setting, intra-tissular galectin-3 might be a more relevant biomarker of disease activity and a predictor of response to galectin-3 inhibitor treatment2. 1 Goodman, et al."

IO biomarker • Cardiovascular • Fibrosis • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis • Oncology • Portal Hypertension • LGALS3

HEPATIC EXPRESSION OF GALECTIN-3, A PRO-FIBROTIC AND PRO-INFLAMMATORY MARKER. AN IMMUNOHISTOCHEMICAL SURVEY (AASLD 2022) - "In normal livers galectin-3 is only expressed in biliary epithelium and nerves. In inflammatory diseases, galectin-3 is predominantly expressed is activated liver macrophages, and it is only expressed in hepatocytes in cirrhosis. Future studies will include development of morphometric techniques for quantification of galectin-3 in inflammatory and epithelial cells to evaluate therapeutic response to galectin-3 inhibitors."

Fibrosis • Gastroenterology • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Non-alcoholic Steatohepatitis • Oncology • LGALS3

[VIRTUAL] DISTRIBUTION OF THE AST/ALT (DE RITIS) RATIO IN A COHORT OF PATIENTS WITH NASH CIRRHOSIS AND PORTAL HYPERTENSION AND CORRELATION WITH PORTAL PRESSURE (AASLD 2021) - P2 | " Patients participated in a Phase 2 clinical trial of belapectin, a galectin-3 inhibitor (NCT02462967) and the corresponding baseline data were explored... An AST/ ALT (de Ritis) ratio > 1 is frequently seen in patients with compensated NASH cirrhosis and portal hypertension . This ratio is strongly correlated with HVPG . The AST/ALT ratio could help physicians to suspect cirrhosis in a patient with NAFLD and, when cirrhosis is present, to provide information on the degree of portal hypertension ."

Clinical • Fibrosis • Gastroenterology • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Portal Hypertension

[VIRTUAL] PHARMACOKINETIC EXPOSURE AND SAFETY OF BELAPECTIN, A CANDIDATE TREATMENT FOR NASH-CIRRHOSIS, IN PATIENTS WITH HEPATIC INSUFICIENCY (AASLD 2021) - P1 | "Background: Belapectin, a galectin-3 inhibitor, is currently in phase 2b/3 development for the prevention of esophageal varices in patients with NASH cirrhosis... Belapectin, at 4 mg/kg.LBM the highest dose used in the phase 2b/3 program, was well tolerated, and appeared safe . Hepatic impairment did not affect the PK profile of belapectin, suggesting that no dose adjustment is required with advancing disease. The PK profile is consistent with the distribution of belapectin from the blood compartment to parenchymal macrophages which constitute both a reservoir for the drug and the main site of action to inhibit galectin-3 ."

Clinical • PK/PD data • Fibrosis • Gastroenterology • Hematological Disorders • Hepatitis C • Hepatology • Immunology • Inflammation • Liver Failure • Non-alcoholic Steatohepatitis • Pain • LGALS3

[VIRTUAL] MECHANISM OF GALECTIN-3 BINDING BY BELAPECTIN, A GALECTIN-3 INHIBITOR DEVELOPED FOR NASH CIRRHOSIS (AASLD 2021) - "Belapectin binds to the S-face and F-face of the CRD domain of Gal-3 and perturbs its NT domain . With these interactions, belapectin not only interferes with the binding function of Gal-3 but may also impact its spatial configuration and plasticity. This may have beneficial therapeutic implications and differentiates belapectin from small molecule inhibitors of Gal-3 with exclusive binding on the CRD domain ."

Fibrosis • Gastroenterology • Hepatology • Hypertension • Immunology • Inflammation • Non-alcoholic Steatohepatitis • Portal Hypertension • LGALS3

[VIRTUAL] INNOVATING IN CIRRHOSIS: NAVIGATE, A SEAMLESS, ADAPTIVE, PHASE 2b/3 OF BELAPECTIN, A GALECTIN-3 INHIBITOR, FOR THE PREVENTION OF ESOPHAGEAL VARICES IN NASH CIRRHOSIS (AASLD 2021) - P2b | "This ongoing phase 2b/3 study will provide belapectin’s risk benefit for NASH cirrhosis patients, either at the end of phase 2b, at the end of phase 3, or both . 1 FDA . Adaptive Designs for Clinical Trials of Drugs and Biologics."

P2/3 data • P2b data • Fibrosis • Gastroenterology • Hepatology • Hypertension • Immunology • Non-alcoholic Steatohepatitis • Portal Hypertension

Enhancing clinical and immunological effects of anti-PD-1 with belapectin, a galectin-3 inhibitor. (PubMed, J Immunother Cancer) - P1 | "Belapectin+pembrolizumab therapy has activity in MM and HNSCC. Increased Gal-3 expression, expansion of effector memory T cells, and decreased M-MDSCs correlated with clinical response. Further investigation is planned."

Clinical • IO biomarker • Journal • Head and Neck Cancer • Immunology • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-L1

Galectin Therapeutics’ President and CEO Dr. Harold Shlevin to Present at the 3rd Global NASH Congress 2020 (GlobeNewswire, Galectin Therapeutics Inc.) - "In his presentation, titled 'Clinical development of belapectin (GR-MD-02), a galectin-3 inhibitor, in treatment of NASH cirrhosis,' Dr Shlevin will discuss how Galectin-3 inhibition has been shown to be central to the fibrotic process involved in the development of NASH-related cirrhosis, and how belapectin (GR-MD-02), the company’s galectin-3 inhibitor, has been demonstrated in a Phase 2b trial to decrease hepatic venous pressure gradient in compensated NASH cirrhotic patients without varices at baseline."

Clinical • Clinical data