Galectin Therapeutics presents NAVIGATE trial findings on portal hypertension in MASH cirrhosis at AASLD 2024. Results expected December 2024.
Quiver AI Summary
Galectin Therapeutics, Inc. has announced updates on the NAVIGATE trial, which is focused on treating patients with MASH cirrhosis and portal hypertension, at the AASLD 2024 Liver Meeting. The trial utilizes non-invasive tests and adheres to the latest guidelines for portal hypertension. Key findings indicate that a centralized review system can effectively evaluate esophagogastoduodenoscopy (EGD) results in a large multi-center setting and that around a third of trial participants with MASH cirrhosis have undetected esophageal varices, reinforcing the necessity for routine screening in this population. The trial's readout is expected in December 2024, and several posters detailing patient baseline characteristics and findings from the EGD evaluations will be presented at the conference. Galectin's lead drug, belapectin, is aimed at improving outcomes in chronic liver diseases and has received Fast Track designation from the FDA.
Potential Positives
- Galectin Therapeutics is presenting significant findings from the NAVIGATE trial at a prestigious event, highlighting the ongoing commitment to advancing clinical research in a high-unmet-need population.
- The trial's centralized evaluation system is noted for its effectiveness, which could lead to more consistent assessments of critical endpoints in portal hypertension trials.
- Approximately one-third of screened patients were found to have esophageal varices, emphasizing the necessity for reliable screening methods, which may enhance treatment opportunities and patient outcomes.
- The upcoming NAVIGATE trial readout is on track for December 2024, maintaining investor interest and providing a clear timeline for anticipated results.
Potential Negatives
- Approximately one-third of patients with MASH cirrhosis and portal hypertension screened for the NAVIGATE trial had incidental findings of varices, indicating a potential oversight in the patient management and screening processes.
- The reliance on a centralized evaluation system for assessing esophageal and gastric varices may raise concerns about the consistency and effectiveness of the evaluations across multiple centers.
- Advancement of additional clinical programs is largely dependent on finding a suitable partner, which may indicate challenges in securing funding or collaboration for further developments.
FAQ
What is the NAVIGATE trial focused on?
The NAVIGATE trial studies belapectin for preventing esophageal varices in patients with MASH cirrhosis and portal hypertension.
What percentage of patients had varices during screening?
Approximately one third of patients screened had detectable esophageal varices on EGD, highlighting screening needs.
When is the NAVIGATE trial readout expected?
The NAVIGATE trial readout is scheduled for December 2024.
What was presented at the AASLD annual meeting?
Three posters detailing clinical data from the NAVIGATE trial were presented at the AASLD annual meeting.
What is belapectin's significance in the trial?
Belapectin is a galectin-3 inhibitor with Fast Track designation for treating MASH cirrhosis, addressing a major medical need.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
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
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
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.
Poster #4063:
Baseline patients' characteristics from NAVIGATE, a seamless adaptive Phase 2b/3 trial of Belapectin in MASH cirrhosis and portal hypertension.
Presenter:
Khurram Jamil, M.D., Chief Medical Officer, Galectin Therapeutics.
Poster #4125:
In patients with compensated MASH cirrhosis with platelet count < 150,000/μL and radiologic findings of portal hypertension, a third are identified with esophageal varices on screening Esophago-Gastroduodenoscopy.
Presenter:
Laura Ladron deGuevar, M.D., CIAID - Centro de Investigacion y Atencion Integral Durango, S.C.
The three abstracts are available for viewing by attendees on the AASLD website and will also be featured in the October supplement to the AASLD journal,
Hepatology
.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin's lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at
.
Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com
Chris Calabrese
ccalabrese@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor belapectin.
