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NORCROSS, Ga. - Galectin Therapeutics Inc. (NASDAQ:GALT), a biopharmaceutical company with a market capitalization of $87.19 million focused on the development of treatments for liver disease and cancer, announced positive results from its NAVIGATE trial at the European Association for the Study of the Liver (EASL) 2025 Congress in Amsterdam on May 10, 2025. According to InvestingPro data, the company is currently trading near its Fair Value, though it faces financial challenges with a weak overall health score. The study evaluated the efficacy of belapectin, a galectin-3 inhibitor, in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.
The NAVIGATE trial, a global, multicenter, randomized, double-blind, placebo-controlled study, involved 355 patients who were treated with intravenous belapectin or placebo every other week for 18 months. The primary endpoint was the prevention of esophageal varices, a serious complication of portal hypertension.
In the per-protocol population of 287 patients, those treated with belapectin at a dose of 2 mg/kg of lean body mass (LBM) experienced a 49.3% reduction in the incidence of new varices compared to the placebo group, a statistically significant result (p=0.04). The 4 mg/kg LBM dose also showed a reduction in new varices compared to placebo, although the result was not statistically significant.
Additionally, the study reported that fewer patients in the belapectin treatment arms experienced worsening of liver stiffness, a marker of liver fibrosis progression, as measured by FibroScan®. Specifically, patients in the 2 mg/kg group had a significant reduction in liver stiffness compared to the placebo group. These results come as the company’s stock has experienced significant volatility, with InvestingPro data showing a 53.38% decline over the past six months, though it maintains a relatively low beta of 0.63, indicating less volatility compared to the broader market.
The safety profile of belapectin was also noted as encouraging, with the incidence of adverse events and serious adverse events being comparable across the treatment and placebo groups.
Dr. Naim Alkhouri, MD, Chief Academic Officer of Summit Clinical Research, highlighted the significance of the study’s findings, stating that belapectin has the potential to address an unmet need in patients with MASH cirrhosis and clinically significant portal hypertension. Dr. Naga Chalasani, a professor at Indiana University School of Medicine, added that the NAVIGATE study provides meaningful new evidence supporting belapectin’s therapeutic potential.
Galectin Therapeutics aims to develop novel therapies for chronic liver diseases and cancer, with belapectin being its lead drug candidate. The company’s development program for belapectin has received Fast Track designation by the U.S. Food and Drug Administration for the treatment of MASH cirrhosis.
The reported findings are based on a press release statement from Galectin Therapeutics Inc. and contribute to the growing body of research in the field of liver disease treatment. With the next earnings report due on May 19, 2025, investors are closely watching the company’s financial metrics. InvestingPro subscribers have access to additional insights, including 6 key ProTips and comprehensive financial analysis that can help evaluate the company’s potential amid its development milestones.
In other recent news, Galectin Therapeutics Inc. reported significant findings from its NAVIGATE trial, which tested belapectin for Metabolic Dysfunction-Associated SteatoHepatitis (MASH) cirrhosis and portal hypertension. The trial results showed a 68.1% reduction in the incidence of new varices among U.S. patients who adhered to the protocol and were treated with belapectin, compared to those receiving a placebo. This subgroup analysis demonstrated a statistically significant benefit with a p-value of 0.02. Initially, the trial’s top-line results indicated a 43.2% lower incidence of varices at 18 months in patients treated with belapectin versus placebo, though this did not reach statistical significance in the broader intent-to-treat population. Galectin Therapeutics is analyzing further data from patients who completed 36 months of therapy and plans to release additional findings by early 2025. The company is exploring partnerships to advance belapectin’s development and its clinical programs in cancer immunotherapy. CEO Joel Lewis highlighted the pressing need for effective treatments, given the lack of FDA-approved therapies for MASH cirrhosis. The potential of belapectin is underscored by its Fast Track designation by the U.S. Food and Drug Administration.
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