Sagimet Biosciences Announces Upcoming Presentations at EASL Congress 2025
Sagimet Biosciences (Nasdaq: SGMT) has announced three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 study of denifanstat in MASH at the upcoming EASL Congress 2025 in Amsterdam.
The presentations include: 1) An assessment of the MASH Resolution Index (MR-I) as a non-invasive biomarker for detecting MASH resolution, 2) Analysis of denifanstat's effect on bile acid levels and their correlation with histological improvements, and 3) Evaluation of denifanstat's antifibrotic effects using qFibrosis-based collagen features in high-risk patients.
All presentations will take place at the RAI Convention Centre, with two sessions scheduled for May 7 and one for May 10, 2025. Dr. Rohit Loomba from UC San Diego will present two posters, while Dr. Mary E. Rinella from University of Chicago will present the third.
Denifanstat, Sagimet's lead drug candidate, has received FDA Breakthrough Therapy designation for treating non-cirrhotic MASH with moderate to advanced liver fibrosis and is advancing to Phase 3 development.
Sagimet Biosciences (Nasdaq: SGMT) ha annunciato tre presentazioni poster che mostrano analisi aggiuntive dello studio di Fase 2b FASCINATE-2 su denifanstat nella MASH, in programma al prossimo Congresso EASL 2025 ad Amsterdam.
Le presentazioni includono: 1) Una valutazione del MASH Resolution Index (MR-I) come biomarcatore non invasivo per rilevare la risoluzione della MASH, 2) Analisi dell’effetto di denifanstat sui livelli di acidi biliari e la loro correlazione con i miglioramenti istologici, e 3) Valutazione degli effetti antifibrotici di denifanstat utilizzando caratteristiche di collagene basate su qFibrosis in pazienti ad alto rischio.
Tutte le presentazioni si terranno presso il RAI Convention Centre, con due sessioni programmate per il 7 maggio e una per il 10 maggio 2025. Il Dr. Rohit Loomba dell’UC San Diego presenterà due poster, mentre la Dr.ssa Mary E. Rinella dell’Università di Chicago presenterà il terzo.
Denifanstat, il principale candidato farmaco di Sagimet, ha ricevuto la designazione FDA Breakthrough Therapy per il trattamento della MASH non cirrotica con fibrosi epatica da moderata ad avanzata ed è in fase di sviluppo avanzato verso la Fase 3.
Sagimet Biosciences (Nasdaq: SGMT) ha anunciado tres presentaciones en formato póster que muestran análisis adicionales del estudio Fase 2b FASCINATE-2 sobre denifanstat en MASH, que se presentarán en el próximo Congreso EASL 2025 en Ámsterdam.
Las presentaciones incluyen: 1) Una evaluación del Índice de Resolución de MASH (MR-I) como biomarcador no invasivo para detectar la resolución de MASH, 2) Análisis del efecto de denifanstat sobre los niveles de ácidos biliares y su correlación con las mejoras histológicas, y 3) Evaluación de los efectos antifibróticos de denifanstat utilizando características de colágeno basadas en qFibrosis en pacientes de alto riesgo.
Todas las presentaciones se realizarán en el Centro de Convenciones RAI, con dos sesiones programadas para el 7 de mayo y una para el 10 de mayo de 2025. El Dr. Rohit Loomba de UC San Diego presentará dos pósters, mientras que la Dra. Mary E. Rinella de la Universidad de Chicago presentará el tercero.
Denifanstat, el principal candidato a medicamento de Sagimet, ha recibido la designación de Terapia Innovadora (Breakthrough Therapy) por la FDA para el tratamiento de MASH no cirrótica con fibrosis hepática de moderada a avanzada y avanza hacia el desarrollo de Fase 3.
Sagimet Biosciences (나스닥: SGMT)는 2025년 암스테르담에서 열리는 EASL 학회에서 MASH에 대한 데니판스타트(denifanstat)의 2b상 FASCINATE-2 연구 추가 분석을 담은 세 편의 포스터 발표를 발표했습니다.
발표 내용은 다음과 같습니다: 1) MASH 해소를 감지하기 위한 비침습적 바이오마커로서 MASH Resolution Index(MR-I) 평가, 2) 데니판스타트가 담즙산 수치에 미치는 영향 및 조직학적 개선과의 상관관계 분석, 3) 고위험 환자에서 qFibrosis 기반 콜라겐 특성을 이용한 데니판스타트의 항섬유화 효과 평가.
모든 발표는 RAI 컨벤션 센터에서 진행되며, 2025년 5월 7일에 두 세션, 5월 10일에 한 세션이 예정되어 있습니다. UC 샌디에이고의 로히트 룸바 박사가 두 편의 포스터를, 시카고 대학교의 메리 E. 리넬라 박사가 한 편을 발표합니다.
Sagimet의 주요 후보 약물인 데니판스타트는 비경변성 MASH 환자 중 중등도에서 고도 간 섬유증 치료를 위해 FDA의 혁신 치료제 지정(Breakthrough Therapy designation)을 받았으며, 현재 3상 개발 단계에 진입하고 있습니다.
Sagimet Biosciences (Nasdaq : SGMT) a annoncé trois présentations sous forme de posters présentant des analyses supplémentaires de l’étude de phase 2b FASCINATE-2 sur le denifanstat dans la MASH lors du prochain Congrès EASL 2025 à Amsterdam.
Les présentations comprennent : 1) Une évaluation de l’Indice de Résolution de la MASH (MR-I) en tant que biomarqueur non invasif pour détecter la résolution de la MASH, 2) Une analyse de l’effet du denifanstat sur les niveaux d’acides biliaires et leur corrélation avec les améliorations histologiques, et 3) Une évaluation des effets antifibrotiques du denifanstat en utilisant des caractéristiques de collagène basées sur qFibrosis chez des patients à haut risque.
Toutes les présentations auront lieu au RAI Convention Centre, avec deux sessions prévues le 7 mai et une le 10 mai 2025. Le Dr Rohit Loomba de l’UC San Diego présentera deux posters, tandis que le Dr Mary E. Rinella de l’Université de Chicago présentera le troisième.
Denifanstat, principal candidat médicament de Sagimet, a reçu la désignation de thérapie révolutionnaire (Breakthrough Therapy) de la FDA pour le traitement de la MASH non cirrhotique avec fibrose hépatique modérée à avancée et progresse vers le développement de phase 3.
Sagimet Biosciences (Nasdaq: SGMT) hat drei Posterpräsentationen mit zusätzlichen Analysen der Phase-2b-Studie FASCINATE-2 zu denifanstat bei MASH auf dem kommenden EASL-Kongress 2025 in Amsterdam angekündigt.
Die Präsentationen umfassen: 1) Eine Bewertung des MASH Resolution Index (MR-I) als nicht-invasiver Biomarker zur Erkennung der MASH-Auflösung, 2) Analyse der Wirkung von denifanstat auf Gallensäurespiegel und deren Korrelation mit histologischen Verbesserungen, und 3) Bewertung der antifibrotischen Effekte von denifanstat anhand von qFibrosis-basierten Kollagenmerkmalen bei Hochrisikopatienten.
Alle Präsentationen finden im RAI Convention Centre statt, mit zwei Sitzungen am 7. Mai und einer am 10. Mai 2025. Dr. Rohit Loomba von der UC San Diego wird zwei Poster vorstellen, während Dr. Mary E. Rinella von der University of Chicago das dritte präsentiert.
Denifanstat, der führende Arzneimittelkandidat von Sagimet, hat die FDA Breakthrough Therapy Designation für die Behandlung von nicht-zirrhotischer MASH mit mittelschwerer bis fortgeschrittener Leberfibrose erhalten und befindet sich in der Entwicklung der Phase 3.
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SAN MATEO, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that three poster presentations featuring additional analyses from the Phase 2b FASCINATE-2 study of denifanstat in MASH will be presented at the European Association for the Study of Liver (EASL) Congress 2025 being held May 7-10, 2025 in Amsterdam, Netherlands.
EASL Presentation Details:
| Title: | Assessment of the metabolic dysfunction-associated steatohepatitis resolution index and component biomarkers in prediction of histology response to denifanstat in the FASCINATE-2 trial |
| Presenter: | Rohit Loomba, MD, University of California, San Diego School of Medicine, San Diego |
| Session: | Poster – MASLD: Diagnostics and non-invasive assessment |
| Date/Time: | Wednesday, May 7, 2025, 8:30 AM CEST |
| Location: | Poster area, RAI Convention Centre, Amsterdam |
| Key Poster Highlights: This retrospective analysis evaluated the performance of the MASH Resolution Index (MR-I), a non-invasive biomarker score, in detecting histologic resolution of MASH in the Phase 2b FASCINATE-2 trial of denifanstat. Results demonstrated that, in patients treated with denifanstat, MR-I can predict MASH resolution and potentially can predict non-responders. Additional analyses of the MR-I results are underway to identify an alternative endpoint to the more invasive liver biopsy. | |
| Title: | Denifanstat-mediated reduction of plasma glycine- and taurine-conjugated bile acids correlates with histological improvements in denifanstat-treated metabolic dysfunction-associated steatohepatitis patients in phase 2b FASCINATE-2 study |
| Presenter: | Rohit Loomba, MD, University of California San Diego School of Medicine, San Diego |
| Session: | Poster – MASLD: Diagnostics and non-invasive assessment |
| Date/Time: | Wednesday, May 7, 2025, 8:30 AM CEST |
| Location: | Poster area, RAI Convention Centre, Amsterdam |
| Key Poster Highlights: Elevated serum bile acid levels have been associated with metabolic disorders, such as MASH and type 2 diabetes. In MASH patients from the Phase 2b FASCINATE-2 trial treated with denifanstat, glycine- and taurine-conjugated bile acids were significantly reduced at 26 weeks in histological responders for both fibrosis regression and MASH resolution. These data suggest that these circulating bile acid levels may be leveraged as a response biomarker in patients treated with denifanstat. | |
| Title: | Denifanstat improves multiple qFibrosis-based collagen features linked to major adverse liver outcomes in patients with metabolic dysfunction-associated steatohepatitis and high polygenic risk |
| Presenter: | Mary E. Rinella, MD, University of Chicago Pritzker School of Medicine, Chicago U.S. |
| Session: | Poster – MASLD: Therapy |
| Date/Time: | Saturday, May 10, 2025, 8:30 AM CEST |
| Location: | Poster area, RAI Convention Centre, Amsterdam |
| Key Poster Highlights: Denifanstat demonstrated antifibrotic effect in qFibrosis-based collagen features previously linked to major adverse liver outcomes (MALO) using digital pathology techniques. Pronounced antifibrotic effects were observed with denifanstat treatment in the difficult-to-treat population with several risk variants associated with MALO. | |
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into Phase 3 development in MASH. For additional information about Sagimet, please visit www.sagimet.com.
About MASH
Metabolic-dysfunction associated steatohepatitis (MASH) is a progressive and severe liver disease which is estimated to impact more than 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions.
The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat or any other drug candidates Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines, including its Phase 3 denifanstat program and Phase 1 acne program; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
FAQ
What are the key findings from SGMT's FASCINATE-2 trial presented at EASL 2025?
How does denifanstat's MASH Resolution Index (MR-I) perform in predicting treatment outcomes?
What is the significance of denifanstat's FDA Breakthrough Therapy designation for MASH treatment?
When and where will Sagimet (SGMT) present its FASCINATE-2 trial results at EASL 2025?
What biomarker changes were observed in SGMT's denifanstat-treated MASH patients?
