Galectin Therapeutics Presents Three Abstracts at the American Association for the Study of Liver Diseases (AASLD) 2024 Liver Meeting
Galectin Therapeutics (NASDAQ: GALT) presented three posters at AASLD 2024 Liver Meeting regarding their ongoing NAVIGATE trial for belapectin in MASH cirrhosis patients with portal hypertension. Key findings include: approximately one-third of screened patients had esophageal varices, demonstrating the importance of screening. The company established an effective centralized evaluation system for assessing esophageal and gastric varices in clinical research. The NAVIGATE trial readout remains on schedule for December 2024.
Galectin Therapeutics (NASDAQ: GALT) ha presentato tre poster al Congresso AASLD 2024 sul loro studio NAVIGATE in corso riguardante belapectin nei pazienti con cirrosi MASH e ipertensione portale. I risultati chiave includono: circa un terzo dei pazienti screening aveva varici esofagee, dimostrando l'importanza dello screening. L'azienda ha istituito un efficace sistema di valutazione centralizzato per la valutazione delle varici esofagee e gastriche nella ricerca clinica. I risultati dello studio NAVIGATE sono in programma per domenica dicembre 2024.
Galectin Therapeutics (NASDAQ: GALT) presentó tres carteles en la reunión del hígado AASLD 2024 sobre su ensayo NAVIGATE en curso para belapectin en pacientes con cirrosis MASH y hipertensión portal. Los hallazgos clave incluyen: aproximadamente un tercio de los pacientes examinados tenía varices esofágicas, lo que demuestra la importancia del examen. La empresa estableció un sistema de evaluación centralizado eficaz para evaluar las varices esofágicas y gástricas en la investigación clínica. La lectura del ensayo NAVIGATE sigue programada para diciembre de 2024.
Galectin Therapeutics (NASDAQ: GALT)는 MASH 간경변 환자와 문맥고혈압 환자를 대상으로 하는 belapectin의 NAVIGATE 임상시험과 관련하여 AASLD 2024 간 회의에서 세 개의 포스터를 발표했습니다. 주요 발견 사항으로는: 스크리닝된 환자의 약 3분의 1이 식도 정맥류를 가지고 있어 스크리닝의 중요성을 보여줍니다. 이 회사는 임상 연구에서 식도 및 위 정맥류를 평가하기 위한 효과적인 중앙 집중식 평가 시스템을 구축했습니다. NAVIGATE 시험 결과 발표는 2024년 12월로 예정되어 있습니다.
Galectin Therapeutics (NASDAQ: GALT) a présenté trois affiches lors de la réunion du foie AASLD 2024 concernant leur essai NAVIGATE en cours pour belapectin chez des patients atteints de cirrhose MASH avec hypertension portale. Les principales conclusions incluent : environ un tiers des patients examinés avaient des varices œsophagiennes, ce qui souligne l'importance du dépistage. L'entreprise a établi un système d'évaluation centralisé efficace pour évaluer les varices œsophagiennes et gastriques dans la recherche clinique. Les résultats de l'essai NAVIGATE sont toujours prévus pour décembre 2024.
Galectin Therapeutics (NASDAQ: GALT) hat auf dem AASLD 2024 Liver Meeting drei Poster zu ihrer laufenden NAVIGATE-Studie zu belapectin bei MASH-Zirrhose-Patienten mit portaler Hypertension vorgestellt. Die wichtigsten Erkenntnisse sind: Ungefähr ein Drittel der gescreenten Patienten hatte ösophageale Varizen, was die Bedeutung von Screenings verdeutlicht. Das Unternehmen hat ein effektives zentrales Bewertungssystem zur Beurteilung von ösophagealen und gastric Varizen in der klinischen Forschung etabliert. Die Ergebnisse der NAVIGATE-Studie sind wie geplant für Dezember 2024 angesetzt.
- NAVIGATE trial remains on track for December 2024 readout
- Successfully established centralized evaluation system for varices assessment
- Clinical trial progress demonstrates advancement in treating high unmet medical need
- None.
Insights
Conference presentations reveal critical insights about the NAVIGATE trial for belapectin in MASH cirrhosis patients. Three key findings stand out: 33% of screened patients showed esophageal varices, validating the urgent medical need; the trial successfully implemented a centralized EGD evaluation system; and the patient selection criteria align with current portal hypertension guidelines.
The most significant aspect is the upcoming trial readout in December 2024, which could be pivotal for MASH cirrhosis treatment. The data presented demonstrates robust trial design and execution, particularly in standardizing varices assessment. The high incidence of varices in the screened population suggests a substantial market opportunity if belapectin proves effective.
While these presentations don't provide efficacy data, they establish strong trial methodology and validate the target patient population, building credibility for the upcoming results.
- 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 www.galectintherapeutics.com.
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.
FAQ
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