NORCROSS, Ga. - Galectin Therapeutics Inc. (NASDAQ: NASDAQ:GALT), a biopharmaceutical company focused on the development of therapeutics targeting galectin-3, announced today that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation without modifications of the NAVIGATE study.
This adaptive Phase 2b/3 clinical trial is evaluating the safety and efficacy of belapectin in patients with cirrhotic portal hypertension caused by metabolic dysfunction-associated steatohepatitis (MASH).
The NAVIGATE study, a global, randomized, placebo-controlled, double-blind trial, aims to assess the prevention of esophageal varices, a serious complication of liver cirrhosis. The trial's innovative design is structured in two stages, with the first stage fully enrolled with 357 patients. These patients have been randomized to receive bi-weekly infusions of either belapectin at two dosage levels or a placebo.
The DSMB's fifth positive recommendation follows an unblinded review of the collected data and supports the favorable tolerability and safety profile of belapectin. The interim analysis of safety and efficacy is scheduled once the last patient in Stage 1 has completed an 18-month follow-up and undergone a second esophago-gastric endoscopy. The results will determine the trial's progression into Stage 2 (Phase 3) and the necessary protocol adaptations for that phase.
Dr. Pol Boudes, Chief Medical Officer of Galectin Therapeutics, expressed confidence in the safety of belapectin, highlighting its importance due to the multiple medications and co-morbidities present in the patient population of the trial. The topline results from the interim analysis are expected in the fourth quarter of 2024.
Belapectin is a complex carbohydrate drug that inhibits galectin-3, a protein implicated in various inflammatory and fibrotic diseases. Previous studies have suggested that belapectin may prevent the development of esophageal varices in MASH cirrhosis, providing the basis for the ongoing NAVIGATE trial.
The continuation of the NAVIGATE study represents a significant step in addressing the unmet medical need for effective treatments for liver cirrhosis due to MASH, a condition affecting millions in the U.S. and leading to liver transplantation as the only curative treatment. This press release statement is the source of the information reported.
InvestingPro Insights
As Galectin Therapeutics (NASDAQ: GALT) continues its critical NAVIGATE study for belapectin, investors have been closely monitoring the company's performance. Recent data from InvestingPro shows a remarkable surge in the stock's price with a one-week total return of 49.0% and an impressive year-to-date return of 125.3%. This bullish trend is further evidenced by the stock trading near its 52-week high, at 99.73% of the peak value.
Despite these strong returns, InvestingPro Tips indicate that the stock may be in overbought territory based on its Relative Strength Index (RSI). Additionally, analysts following the company have voiced concerns regarding its profitability, with expectations of net income dropping this year and a consensus that the company may not achieve profitability within the same timeframe. This juxtaposition of strong market performance against profitability concerns underscores the complexity of evaluating biopharmaceutical investments.
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