NORCROSS, Ga. - Galectin Therapeutics Inc. (NASDAQ: NASDAQ:GALT), a clinical-stage biotech company with a current market capitalization of $125.52 million, revealed results from its NAVIGATE clinical trial, indicating that belapectin may reduce the development of esophageal varices in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension. According to InvestingPro analysis, the stock is currently trading near its Fair Value despite showing a 20.48% gain year-to-date. The trial, encompassing over 130 sites on five continents, involved 355 patients who received belapectin or placebo for 18 months.
In the per-protocol population, those who completed the trial with required endoscopies, belapectin at 2mg/kg of lean body mass showed a 48.9% reduction in the incidence of varices compared to placebo, achieving statistical significance with a p-value less than 0.05. However, in the broader intent-to-treat population, the drug did not meet the primary endpoint of statistical significance.
Non-invasive measures supported these findings, with liver stiffness assessments showing a 50% lower number of subjects with worsening stiffness among those treated with belapectin. The safety profile was also encouraging, with comparable rates of adverse events and serious adverse events across all cohorts.
While the 4 mg/kg dose did not increase efficacy, likely due to saturable binding dynamics with galectin-3 proteins, the 2 mg dose appears to offer optimal therapeutic effects. Dr. Khurram Jamil, Chief Medical (TASE:PMCN) Officer at Galectin Therapeutics, expressed encouragement by the results at 18 months and anticipates further updates from ongoing analyses, including additional biomarker data expected in early 2025.
The company remains optimistic about belapectin's potential and is grateful to the trial participants. Dr. Naim Alkhouri and Dr. Naga Chalasani, both involved in liver health research, voiced support for the drug's continued development given the significant unmet need for treatments in patients with MASH cirrhosis. InvestingPro data reveals the company faces financial challenges with a weak overall health score, while analysts maintain an $11 price target, suggesting significant upside potential. Subscribers can access 4 additional ProTips and comprehensive financial metrics for deeper analysis.
Galectin Therapeutics is committed to improving the lives of patients with chronic liver disease and cancer and is actively seeking pharmaceutical partnerships to advance belapectin's development. With a current ratio of 1.13 and negative earnings per share of -$0.73, the company faces financial challenges as it pursues these developments. The information reported is based on a press release statement from Galectin Therapeutics.
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