Galectin Therapeutics Reports Significant Reduction in New Varices with Belapectin in U.S. Patient Population from the NAVIGATE Trial
Galectin Therapeutics (NASDAQ: GALT) has reported additional results from its NAVIGATE trial for belapectin in patients with MASH cirrhosis and portal hypertension. The analysis revealed a statistically significant 68.1% reduction (p=0.02) in new varices incidence with belapectin versus placebo in U.S. per-protocol patients.
While the trial's initial composite endpoint didn't reach statistical significance in the intent-to-treat population (N=355), the completer population of 287 patients showed a 49.3% reduction in varices incidence (p=0.04). The U.S. subset analysis (n=186) demonstrated stronger results, with only 4 out of 60 belapectin-treated patients developing varices compared to 13 out of 62 in the placebo group.
With an estimated 3 million U.S. adults affected by MASH cirrhosis and clinically significant portal hypertension, for which no FDA-approved therapies exist, the company continues analyzing data, including results from approximately 50 patients who completed 36-months of therapy. Additional data is expected by Q1 2025.
Galectin Therapeutics (NASDAQ: GALT) ha riportato ulteriori risultati dal suo studio NAVIGATE per il belapectin in pazienti con cirrosi MASH e ipertensione portale. L'analisi ha rivelato una riduzione statisticamente significativa del 68,1% (p=0,02) nell'incidenza di nuove varici con belapectin rispetto al placebo nei pazienti statunitensi per protocollo.
Sebbene l'endpoint composito iniziale dello studio non abbia raggiunto significatività statistica nella popolazione intent-to-treat (N=355), la popolazione di completamento di 287 pazienti ha mostrato una riduzione del 49,3% nell'incidenza di varici (p=0,04). L'analisi del sottogruppo statunitense (n=186) ha dimostrato risultati più forti, con solo 4 su 60 pazienti trattati con belapectin che hanno sviluppato varici rispetto a 13 su 62 nel gruppo placebo.
Con un numero stimato di 3 milioni di adulti negli Stati Uniti affetti da cirrosi MASH e ipertensione portale clinicamente significativa, per la quale non esistono terapie approvate dalla FDA, l'azienda continua ad analizzare i dati, inclusi i risultati di circa 50 pazienti che hanno completato 36 mesi di terapia. Ulteriori dati sono attesi entro il primo trimestre del 2025.
Galectin Therapeutics (NASDAQ: GALT) ha reportado resultados adicionales de su ensayo NAVIGATE para belapectin en pacientes con cirrosis MASH e hipertensión portal. El análisis reveló una reducción estadísticamente significativa del 68,1% (p=0,02) en la incidencia de nuevas varices con belapectin en comparación con placebo en pacientes estadounidenses por protocolo.
Aunque el objetivo compuesto inicial del ensayo no alcanzó significancia estadística en la población intent-to-treat (N=355), la población completadora de 287 pacientes mostró una reducción del 49,3% en la incidencia de varices (p=0,04). El análisis del subconjunto estadounidense (n=186) demostró resultados más fuertes, con solo 4 de 60 pacientes tratados con belapectin desarrollando varices en comparación con 13 de 62 en el grupo placebo.
Con un estimado de 3 millones de adultos en EE. UU. afectados por cirrosis MASH e hipertensión portal clínicamente significativa, para la cual no existen terapias aprobadas por la FDA, la empresa continúa analizando datos, incluidos los resultados de aproximadamente 50 pacientes que completaron 36 meses de terapia. Se esperan datos adicionales para el primer trimestre de 2025.
갈렉틴 테라퓨틱스 (NASDAQ: GALT)는 MASH 간경변 및 문맥 고혈압 환자에 대한 벨라펙틴의 NAVIGATE 시험에서 추가 결과를 보고했습니다. 분석 결과, 미국의 프로토콜 환자에서 벨라펙틴과 위약 간의 새로운 변위 발생률에서 통계적으로 유의미한 68.1% 감소 (p=0.02)가 나타났습니다.
시험의 초기 복합 평가 지표는 의도 치료 집단(N=355)에서 통계적 유의성을 달성하지 못했지만, 287명의 완주 집단은 변위 발생률에서 49.3% 감소(p=0.04)를 보여주었습니다. 미국 하위 분석(n=186)은 더 강력한 결과를 보여주었으며, 벨라펙틴 치료를 받은 60명 중 4명만이 변위를 개발한 반면, 위약 그룹에서는 62명 중 13명이 변위를 개발했습니다.
미국에서 MASH 간경변 및 임상적으로 유의미한 문맥 고혈압에 영향을 받는 성인이 약 300만 명으로 추정되며, 이들에 대한 FDA 승인 치료법이 존재하지 않는 상황에서, 회사는 36개월 치료를 완료한 약 50명의 결과를 포함하여 데이터를 계속 분석하고 있습니다. 추가 데이터는 2025년 1분기까지 예상됩니다.
Galectin Therapeutics (NASDAQ: GALT) a rapporté des résultats supplémentaires de son essai NAVIGATE pour le belapectin chez des patients atteints de cirrhose MASH et d'hypertension portale. L'analyse a révélé une réduction statistiquement significative de 68,1% (p=0,02) de l'incidence de nouvelles varices avec le belapectin par rapport au placebo chez les patients américains selon le protocole.
Bien que le critère d'évaluation composite initial de l'essai n'ait pas atteint de signification statistique dans la population en intention de traiter (N=355), la population des patients ayant complété l'étude (287 patients) a montré une réduction de 49,3% de l'incidence des varices (p=0,04). L'analyse du sous-groupe américain (n=186) a montré des résultats plus forts, avec seulement 4 des 60 patients traités par belapectin développant des varices contre 13 des 62 dans le groupe placebo.
Avec environ 3 millions d'adultes américains touchés par la cirrhose MASH et une hypertension portale cliniquement significative, pour laquelle aucune thérapie approuvée par la FDA n'existe, l'entreprise continue d'analyser les données, y compris les résultats d'environ 50 patients ayant complété 36 mois de thérapie. Des données supplémentaires sont attendues d'ici le premier trimestre 2025.
Galectin Therapeutics (NASDAQ: GALT) hat weitere Ergebnisse aus seiner NAVIGATE-Studie zu Belapectin bei Patienten mit MASH-Zirrhose und portaler Hypertonie berichtet. Die Analyse ergab eine statistisch signifikante Reduktion von 68,1% (p=0,02) der Inzidenz neuer Varizen mit Belapectin im Vergleich zu Placebo bei US-Patienten gemäß Protokoll.
Obwohl der anfängliche zusammengesetzte Endpunkt der Studie in der Intent-to-Treat-Population (N=355) keine statistische Signifikanz erreichte, zeigte die Abschlusspopulation von 287 Patienten eine Reduktion der Varizeninzidenz um 49,3% (p=0,04). Die Analyse der US-Untergruppe (n=186) zeigte stärkere Ergebnisse, wobei nur 4 von 60 mit Belapectin behandelten Patienten Varizen entwickelten, verglichen mit 13 von 62 im Placebo-Gruppe.
Mit geschätzten 3 Millionen betroffenen Erwachsenen in den USA, die an MASH-Zirrhose und klinisch signifikanter portaler Hypertonie leiden, für die es keine von der FDA zugelassenen Therapien gibt, analysiert das Unternehmen weiterhin Daten, einschließlich der Ergebnisse von etwa 50 Patienten, die 36 Monate Therapie abgeschlossen haben. Zusätzliche Daten werden bis zum ersten Quartal 2025 erwartet.
- Significant 68.1% reduction in new varices incidence in U.S. patients (p=0.02)
- 49.3% reduction in varices incidence in global completer population (p=0.04)
- Large addressable market of 3 million U.S. adults with MASH cirrhosis
- No current FDA-approved therapies for the condition
- Initial composite endpoint did not reach statistical significance in intent-to-treat population
- Full trial analysis still ongoing, creating uncertainty
- Company seeking potential partners for further development, suggesting possible funding needs
Insights
The NAVIGATE trial results reveal compelling evidence for belapectin's efficacy in preventing esophageal varices in MASH cirrhosis patients. The 68.1% reduction in new varices among U.S. per-protocol patients represents a clinically meaningful outcome, particularly given the statistical significance (p=0.02). This translates to only 4 out of 60 belapectin-treated patients developing varices compared to 13 out of 62 in the placebo group.
The stark difference between the intent-to-treat (ITT) and per-protocol results merits attention. While the ITT analysis showed a 43.2% reduction without statistical significance, the per-protocol analysis demonstrated stronger efficacy. This pattern often indicates that patient adherence and completion of the treatment regimen are important for optimal outcomes.
The enhanced efficacy in U.S. patients, who had higher utilization of GLP-1 agonists and statins, suggests potential synergistic effects worth exploring. This could inform future treatment protocols and patient selection strategies.
The market opportunity is substantial, with an estimated 3 million adults in the U.S. affected by MASH cirrhosis and clinically significant portal hypertension. The absence of FDA-approved therapies for this condition underscores the potential impact of belapectin. Prevention of varices is particularly important as they represent a life-threatening complication of portal hypertension, with bleeding varices carrying a significant mortality risk.
The pending analysis of 36-month treatment data could provide vital insights into long-term efficacy and safety. This extended data will be important for regulatory discussions and potential partnership negotiations, as it may demonstrate sustained benefits beyond the primary 18-month endpoint.
- Additional analysis of data from the NAVIGATE trial showed statistically significant
68.1% (p=0.02) reduction in the incidence of new varices with belapectin vs placebo in per-protocol patients (completers) enrolled in the U.S. - New estimates indicate around 3 million adults in the U.S. suffer from MASH cirrhosis and clinically significant portal hypertension1, for which there are no FDA approved therapies
- Full analysis of the NAVIGATE trial is ongoing; additional data, including from patients completing 36 months of treatment, expected by end of Q1 2025
NORCROSS, Ga., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced additional results showing a statistically significant reduction in new varices in per-protocol patients (completers) enrolled in the U.S. from the NAVIGATE trial for belapectin in patients with Metabolic Dysfunction-Associated SteatoHepatitis (MASH) cirrhosis and portal hypertension.
The NAVIGATE trial top-line results showed that while the incidence of varices at 18 months was
Following the favorable trend observed in the completers, the Company further analyzed the two thirds of the completer patients in the NAVIGATE trial enrolled in the U.S. (n=186). The incidence of varices in this population was significantly reduced by
Joel Lewis, Chief Executive Officer at Galectin Therapeutics commented: “With the prevalence of MASH cirrhosis and clinically significant portal hypertension in the U.S. now estimated in Hepatology at around 3 million adults, the need for new treatments that can prevent disease progression is more urgent than we had anticipated. The significant reduction of
The Company will determine next steps for belapectin development with potential partners in conjunction with the completion of the ongoing analyses.
1Younossi ZM, de Avila L, Racila A, et al. Prevalence and predictors of cirrhosis and portal hypertension in the United States. Hepatology. 2025 Jan 29. doi: 10.1097/HEP.0000000000001243.
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect,” “look forward,” “believe,” “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
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
What were the key results of GALT's NAVIGATE trial for belapectin in U.S. patients?
How many patients completed the NAVIGATE trial for GALT's belapectin?
What is the market size for GALT's belapectin treatment in the U.S.?
When will GALT release additional data from the NAVIGATE trial?
What was the overall efficacy of GALT's belapectin in the NAVIGATE trial?
