Galectin Therapeutics(GALT) - 2024 Q3 - Quarterly Report

Drug Development and Clinical Trials - The company is focused on developing belapectin, a galectin-3 inhibitor, for treating liver fibrosis and cirrhosis in NASH patients, with significant preclinical evidence supporting its efficacy [87]. - A total of 357 patients were randomized in the NAVIGATE trial, which is designed to evaluate the safety and efficacy of belapectin for preventing esophageal varices in MASH cirrhosis patients [88]. - The Phase 2b NASH-CX trial aims to assess the safety and efficacy of belapectin in patients with compensated cirrhosis and portal hypertension, with top-line results expected in December 2024 [97]. - The company has completed two Phase 1 clinical studies and a Phase 2 clinical study in MASH patients with advanced fibrosis, demonstrating the safety of belapectin [87]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND for advanced head and neck cancer in combination with a PD-1 inhibitor [90]. - Belapectin has shown a significant therapeutic effect on liver fibrosis in preclinical models, reducing liver fat, inflammation, and portal pressure [99]. - The Phase 2 NASH-FX trial did not meet its primary endpoint but demonstrated that belapectin was safe and well tolerated [103]. - The NASH-CX trial involved 162 patients with well-compensated MASH cirrhosis and portal hypertension, randomized to receive either belapectin or placebo [104]. - In the total patient population, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose of belapectin, compared to a 0.3 mm Hg change in placebo [105]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [106]. - The belapectin 2 mg/kg LBM group had a significantly lower incidence of new varices (0%) compared to placebo (18%) over the 54-week treatment period [107]. - Belapectin demonstrated a statistically significant improvement in hepatocyte ballooning and a reduction in the development of new esophageal varices (p=0.02) compared to placebo [108]. - The NAVIGATE Trial is a Phase 2b/3 study evaluating belapectin for the prevention of esophageal varices in patients with MASH cirrhosis, targeting a population with unmet medical needs [111]. - The NAVIGATE trial will compare two belapectin doses (2 mg/kg LBM and 4 mg/kg LBM) against placebo, with an interim analysis planned after 18 months of treatment [111]. - The Company activated over 150 clinical trial sites in 14 countries for the NAVIGATE trial, although patient enrollment faced challenges due to the COVID-19 pandemic [120]. - A Hepatic Impairment Study involving approximately 40 patients indicated that belapectin exposure did not increase with the degree of hepatic insufficiency [122]. - Promising results from a Phase 1b trial combining belapectin with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients [125]. Financial and Regulatory Aspects - The company has incurred significant operating losses since inception and relies on additional outside capital for its development programs [86]. - The company is subject to extensive regulation by the FDA, which could impact the commercialization of its product candidates [86]. Insider Trading - Jack Callicutt adopted a Rule 10b5-1 trading plan for the sale of up to 627,456 shares of the Company's common stock until December 31, 2025 [155]. - Khurram Jamil adopted a Rule 10b5-1 trading plan for the sale of shares needed to cover taxes related to a 30,000 RSU grant, plus up to 60% of remaining shares, and an additional 25,000 shares from stock options until December 31, 2025 [156].