In This Article:
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Patient population for the NAVIGATE trial is based on non-invasive tests and clinical criteria utilizing latest treatment guidelines for portal hypertension in MASH cirrhosis
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Blinded central review system can be effectively set-up for evaluation of esophagogastoduodenoscopy (EGD) in large multi-center trial of patients with MASH cirrhosis and portal hypertension, facilitating utilization of this outcome as a critical endpoint in portal hypertension trials
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Approximately a third of patients with MASH cirrhosis and portal hypertension (PH) screened for the NAVIGATE trial had the incidental finding of varices on EGD, highlighting the need for screening EGDs in these patients
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NAVIGATE trial readout on track for December 2024
NORCROSS, Ga., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced the presentation of three posters on the ongoing NAVIGATE trial in patients with MASH cirrhosis and portal hypertension at the American Association for the Study of Liver Diseases (AASLD)’s annual meeting 2024 Liver Meeting, being held November 15-19, 2024 in San Diego, California.
“We are excited to share latest clinical data from our ongoing NAVIGATE trial of belapectin for the prevention of esophageal varices in patients with MASH cirrhosis and portal hypertension. We show that a centralized evaluation system can be designed for consistent and effective assessment of esophageal and gastric varices, which is critical for advancing clinical research in this population with high unmet need. We also provide an in depth look at baseline characteristics of the patient enrolled in our NAVIGATE trial,” said Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics. “In another key finding, our research reveals that among patients with compensated MASH cirrhosis with reduced platelet counts and radiologic signs of portal hypertension, approximately one-third have detectable esophageal varices upon screening. These findings underscore the need for reliable screening and targeted therapies in this vulnerable patient population. These clinical data are of great importance as we look forward to sharing the readout of our NAVIGATE trial before the end of the year.”
The following posters highlighting clinical data will be presented at the “Portal Hypertension and Other Complications of Cirrhosis” session taking place 8:00 am – 5:00 pm on November 18, 2024:
Poster #4118: Evaluation of esophageal and gastric varices in cirrhotic patients with portal hypertension: a central evaluation system for clinical research.
Presenter: Naim Alkhouri, M.D., Arizona Liver Health, Chandler, AZ.