About Galectin Therapeutics

Galectin Therapeutics, Inc. operates as a clinical stage biopharmaceutical company. The company engages in drug research and development to create new therapies for fibrotic disease, cancer and selected other diseases. The company's lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and prevent its complication: the development of esophageal varices. Belapectin has the potential to treat many diseases due to galectin-3's involvement in multiple key biological pathways, such as fibrosis, immune cell function and immunity, cell differentiation, cell growth, and apoptosis (cell death). The company is using its galectin-3 inhibitor to treat advanced liver fibrosis and liver cirrhosis in NASH patients. The company has completed two Phase 1 clinical studies, a Phase 2 clinical study in NASH patients with advanced fibrosis (NASH-FX) and a second Phase 2b clinical trial in NASH patients with compensated cirrhosis and portal hypertension (NASH-CX). In February 2023, the company completed randomizations totaling 357 patients in a large, global Phase 2b/3 clinical trial. The company's study protocol was filed with the U.S. Food and Drug Administration (FDA) on April 30, 2020, for a seamless adaptively-designed Phase 2b/3 clinical study, the NAVIGATE trial, evaluating the safety and efficacy of the company's galectin-3 inhibitor, belapectin, for the prevention of esophageal varices in patients with non-alcoholic steatohepatitis (NASH) cirrhosis. Additionally, a study protocol entitled 'A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment' has been filed with the FDA to examine the effects of the drug in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment; this study became fully enrolled in February 2022. The company has established through its majority-owned joint venture subsidiary, Galectin Sciences LLC, a discovery program developing small molecules that inhibit galectin-3 and may afford alternative drug delivery (e.g., oral) and as a result expand the potential uses of galectin-3 inhibitor beyond belapectin. Three chemical series of composition of matter patents have been filed. The company is also pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in immuno-oncology following its previous successful collaboration with Providence Portland Cancer Center. In 2022, the company filed a new Investigational New Drug (IND) with FDA for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint (PD-1) inhibitor and received a Study May Proceed letter. Strategy The company's strategy is to establish and implement clinical development programs that add value to its business in the shortest period of time possible and to seek strategic partners when one of its programs becomes advanced and requires significant additional resources. Drug Development Programs The company has one new proprietary chemical entity (NCE) in development, belapectin, which has shown promise in preclinical and clinical studies for the treatment of liver fibrosis, severe skin disease, and cancer (melanoma and head and neck squamous cell carcinoma). The company is focusing on development of belapectin for the treatment of NASH cirrhosis and head and neck cancer. Belapectin is a proprietary, patented compound derived from natural, plant-based, starting materials, which following chemical processing, exhibits the properties of binding to and inhibiting galectin-3. The company's Phase 2 program in fibrotic disease consisted of two separate human clinical trials. The main clinical trial was the Phase 2b NASH-CX study for one year for patients with NASH with compensated cirrhosis and portal hypertension, which began enrolling patients in June 2015. This study was a randomized, placebo-controlled, double-blind, parallel-group Phase 2b trial to evaluate the safety and efficacy of belapectin for the treatment of liver fibrosis and resultant portal hypertension in NASH patients with compensated cirrhosis. A smaller, exploratory NASH-FX trial was conducted to explore potential use of various non-invasive imaging techniques in NASH patients with advanced fibrosis but not cirrhosis. NASH-FX Trial: The NASH-FX trial was a Phase 2a pilot trial for patients with NASH and advanced fibrosis that explored use of three non-invasive imaging technologies. It was a short, single site, four-month trial. NASH-CX Trial: The NASH-CX trial was a larger multi-center clinical trial that explored the use of belapectin for the treatment of patients with well-compensated NASH cirrhosis and portal hypertension. Top line data readout was reported in December 2017. The study demonstrated a favorable safety profile and clinically meaningful efficacy results in patients without esophageal varices at baseline as demonstrated by a decrease in portal pressure associated with the prevention of development of varices when compared to placebo. NASH NAVIGATE Trial: Building on the experience of the NASH-CX trial, the NAVIGATE Trial is a seamless adaptively-designed Phase 2b/3 clinical study evaluating the safety and efficacy of the company's galectin-3 inhibitor, belapectin, for the prevention of esophageal varices in patient with non-alcoholic steatohepatitis (NASH) cirrhosis. The study design provides for a pre-specified interim analysis (IA). The company expects topline results from the IA in Fall of 2024. The company has activated more than 150 clinical trial sites in 14 countries for the NAVIGATE trial. The company also has commenced a Hepatic Impairment Study, which will run in parallel with the phase 2b/3 trial as part of the development program. Based on the results from this hepatic impairment study, the company may consider, including patients with more advanced cirrhosis in the Phase 3 portion of its NAVIGATE trial. The company filed an IND with FDA and are planning a phase 2 trial to be filed with the FDA oncology division. Patents and Proprietary Rights In August 2015, the company received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/726,900, titled 'Galactose-pronged polysaccharides in a formulation for antifibrotic therapies'. This patent extends coverage of the company's pectin-derived compounds (including broad molecular weight ranges and other sources of pectin) to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis. Claims in this patent include administering pectin-derived compound parenterally to a patient having at least one of the four aforementioned diseases where the established fibrosis or progression of the fibrosis or cirrhosis is inhibited or slowed down. Additional specific claims encompass deriving the compound from citrus pectin, apple pectin, soybean hull pectin or sugar beet pectin with a molecular weight between 2 kDa and 400kDa. Also covered is the step of administering the modified galacto-rhamnogalacturonan compound in an admixture with a therapeutic agent, where the agent is an antifibrotic compound. In August 2014, the company received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/573,442 titled 'Composition of Novel Carbohydrate Drug for the Treatment of Human Diseases'. The patent covers composition and chemical structural claims for compounds that includes the company's lead galectin inhibitor compound belapectin and will expire in December 2031. Claims include multiple routes of administration, including intravenous, subcutaneous and oral. The application also covers therapeutic formulations for use in the treatment of NASH (fatty liver disease), cancer and fibrotic, inflammatory and autoimmune disorders in which galectin proteins are involved, at least in part, in the pathogenesis. Additional specific claims encompass liver fibrosis, kidney fibrosis, lung fibrosis or heart fibrosis. The patent, assigned U.S. Patent No. 8,871,925, was issued October 28, 2014. In May 2014, the company received notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/998,197 titled 'Galactose-Pronged Carbohydrate Compounds for the Treatment of Diabetic Nephropathy and Associated Disorders'. The patent covers both composition claim for and uses of the company's carbohydrate-based galectin inhibitor compound belapectin in patients with diabetic nephropathy, a type of progressive kidney disease that occurs in individuals with diabetes. Diabetic nephropathy is the major cause for chronic renal failure in the United States. The patent, assigned U.S. Patent No. 8,828,971, was issued September 9, 2014. In February 2014, the company received notice of issuance that the U.S. Patent and Trademark Office issued patent number 8,658,787 to the company for its application titled 'Galacto-rhamnogalacturonate compositions for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease'. The patent covers the company's carbohydrate-based galectin inhibitor compound belapectin for use in patients with fatty liver disease with or without fibrosis or cirrhosis, providing patent protection through 2031. The major claims are for methods of obtaining galectin inhibitor compounds, obtaining a composition for parenteral or enteral administration in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, non-alcoholic hepatitis with liver fibrosis, non-alcoholic steatohepatitis with cirrhosis, or non-alcoholic steatohepatitis with cirrhosis and hepatocellular carcinoma. The use covers reversing or slowing the progression of disease activity or medical consequences of the disease. Applications are pending in multiple countries to extend patent protection globally. In January 2014, the company received a notice of allowance from the U.S. Patent and Trademark Office for Patent Application Number 13/550,962 titled 'Galactose-Pronged Polysaccharides in a Formulation for Anti-fibrotic Therapies'. The patent covers both composition claim for and uses of the company's carbohydrate-based galectin inhibitor compound belapectin for use in patients with liver fibrosis in combination with other potential therapeutic agents. The patent covers use of belapectin with agents directed at multiple targets, some of which are in clinical development for fibrotic disorders, including monoclonal antibodies to connective tissue growth factor, integrins, and TGF-ß1. The patent, assigned U.S. Patent No. 8,722,645, was issued May 13, 2014. In July 2012, the company received a notice of issuance from the U.S. Patent and Trademark Office for the U.S. Patent number 8,236,780 issued on August 7, 2013 titled 'Galactose-prolonged polysaccharides in a formulation for antifibrotic therapies'. This methods patent covers key methods of derivation and use for the company's carbohydrate-based galectin inhibitor compound for use in patients with chronic liver disease associated with the development of fibrosis, established liver fibrosis or end-stage scarring, or cirrhosis. The major claim is for a method of obtaining a galacto-rhamnogalacturan compound from an apple pectin, obtaining a composition for parenteral administration the galacto-rhamnogalacturonan compound in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: chronic liver disease associated with the development of fibrosis, established liver fibrosis or cirrhosis. The use covers inhibiting or slowing the progression of fibrosis. belapectin is covered by this patent and it provides opportunities for the development of additional compounds in the class. As of December 31, 2022, the company held 20 granted U.S. patents, 100 foreign granted, 5 foreign patent applications pending, and 1 U.S. patent applications pending. The scheduled expiration dates of the company's many of its United States patents span out to 2034 before considering any potential extensions. The company has corresponding patent applications pending in various territories where it sees potential for commercial interest. Additionally, the company has patent applications in other areas to utilize its carbohydrate-based compounds to treat disease other than cancer. Galectin Sciences LLC has 3 granted U.S. patents, 11 granted international patents, 2 U.S. patent application pending, and 21 foreign applications pending. Research and Development During the year ended December 31, 2022, the company's expenditures for research and development were $31.7 million. History The company was founded in 2000. It was incorporated in the state of Nevada in 2001. The company was formerly known as Pro-Pharmaceuticals, Inc. and changed its name to Galectin Therapeutics, Inc. in 2011.