Sagimet Biosciences Announces Oral Presentation at the 9th Annual MASH-TAG 2025 Conference
Sagimet Biosciences (Nasdaq: SGMT) announced an upcoming oral presentation at the 9th Annual MASH-TAG Conference in Park City, Utah, from January 9-11, 2025. The presentation, scheduled for January 10 at 6:10 PM MST, will focus on fatty acid synthase (FASN) inhibitors and specifically highlight the differentiated mechanism of action of denifanstat and its anti-fibrotic effects observed in the Phase 2b FASCINATE-2 study in F2/F3 MASH patients.
Dr. Marie O'Farrell, SVP of Research and Development at Sagimet, will present during Session 4: The Promise of New Pharmacological Agents + Pathophysiology. Denifanstat, Sagimet's lead drug candidate, is an oral, once-daily FASN inhibitor that has received FDA Breakthrough Therapy designation for treating non-cirrhotic MASH with moderate to advanced liver fibrosis. Following successful Phase 2b results and FDA end-of-Phase 2 interactions, the drug is advancing to Phase 3 development.
Sagimet Biosciences (Nasdaq: SGMT) ha annunciato una prossima presentazione orale alla 9a Conferenza Annuale MASH-TAG a Park City, Utah, dal 9 all'11 gennaio 2025. La presentazione, programmata per il 10 gennaio alle 18:10 MST, si concentrerà sugli inibitori della sintasi degli acidi grassi (FASN) e metterà in evidenza il meccanismo d'azione differenziato di denifanstat e i suoi effetti antifibrotici osservati nello studio di Fase 2b FASCINATE-2 in pazienti con MASH di stadio F2/F3.
La Dott.ssa Marie O'Farrell, SVP di Ricerca e Sviluppo di Sagimet, presenterà durante la Sessione 4: La promessa di nuovi agenti farmacologici + Fisiopatologia. Denifanstat, il principale candidato farmaceutico di Sagimet, è un inibitore FASN orale, da assumere una volta al giorno, che ha ricevuto la designazione di Terapia Innovativa da parte della FDA per il trattamento del MASH non cirrotico con fibrosi epatica da moderata a avanzata. Dopo i risultati positivi della Fase 2b e le interazioni con la FDA al termine della Fase 2, il farmaco sta avanzando verso lo sviluppo della Fase 3.
Sagimet Biosciences (Nasdaq: SGMT) anunció una próxima presentación oral en la 9ª Conferencia Anual MASH-TAG en Park City, Utah, del 9 al 11 de enero de 2025. La presentación, programada para el 10 de enero a las 6:10 PM MST, se centrará en los inhibidores de la sintasa de ácidos grasos (FASN) y destacará específicamente el mecanismo de acción diferenciado de denifanstat y sus efectos antifibróticos observados en el estudio FASCINATE-2 de Fase 2b en pacientes MASH F2/F3.
La Dra. Marie O'Farrell, SVP de Investigación y Desarrollo de Sagimet, presentará durante la Sesión 4: La Promesa de Nuevos Agentes Farmacológicos + Fisiopatología. Denifanstat, el principal candidato medicinal de Sagimet, es un inhibidor de FASN oral, de administración diaria, que ha recibido la designación de Terapia Innovadora por parte de la FDA para el tratamiento de MASH no cirrótico con fibrosis hepática moderada a avanzada. Tras resultados exitosos en la Fase 2b y las interacciones de la FDA al finalizar la Fase 2, el medicamento está avanzando hacia el desarrollo de la Fase 3.
사기멧 바이오사이언스(SNASDAQ: SGMT)는 2025년 1월 9일부터 11일까지 유타주 파크시티에서 열리는 제9회 연례 MASH-TAG 컨퍼런스에서 구두 발표를 예정하고 있다고 발표했습니다. 1월 10일 오후 6시 10분 MST에 예정된 이 발표에서는 지방산 신타제(FASN) 억제제에 초점을 맞추고, 특히 F2/F3 MASH 환자에 대한 FASCINATE-2 2b 단계 연구에서 관찰된 데니판스타트의 차별화된 작용 기전 및 항섬유화 효과를 강조합니다.
사기멧의 연구 및 개발 부사장인 마리 오파렐 박사는 제4세션: 새로운 약리학적 제제의 약속 + 병리 생리학에서 발표할 예정입니다. 데니판스타트는 사기멧의 주요 후보 약물로, 매일 한 번 복용하는 FASN 억제제로, 비간경화 MASH 치료를 위한 FDA의 혁신 치료 지정서를 받았습니다. 2b 단계 연구의 성공적인 결과와 FDA와의 2단계 종료 상호 작용을 바탕으로, 이 약물은 3단계 개발로 진행되고 있습니다.
Sagimet Biosciences (Nasdaq: SGMT) a annoncé une prochaine présentation orale lors de la 9e Conférence Annuelle MASH-TAG à Park City, Utah, du 9 au 11 janvier 2025. La présentation, prévue pour le 10 janvier à 18h10 MST, se concentrera sur les inhibiteurs de la synthase des acides gras (FASN) et soulignera spécifiquement le mécanisme d'action différencié de denifanstat et ses effets antifibrotiques observés dans l'étude de Phase 2b FASCINATE-2 chez des patients MASH de stade F2/F3.
Dr. Marie O'Farrell, SVP de recherche et développement chez Sagimet, présentera lors de la Session 4 : La promesse de nouveaux agents pharmacologiques + Physiopathologie. Denifanstat, le principal candidat médicament de Sagimet, est un inhibiteur FASN oral à prendre une fois par jour, qui a reçu la désignation de thérapie novatrice de la FDA pour le traitement du MASH non cirrhotique avec fibrose hépatique modérée à avancée. Après des résultats positifs en Phase 2b et des interactions avec la FDA à la fin de la Phase 2, le médicament avance vers le développement en Phase 3.
Sagimet Biosciences (Nasdaq: SGMT) gab eine bevorstehende mündliche Präsentation auf der 9. Jahrestagung der MASH-TAG-Konferenz in Park City, Utah, vom 9. bis 11. Januar 2025 bekannt. Die Präsentation, die für den 10. Januar um 18:10 Uhr MST angesetzt ist, wird sich auf die Inhibitoren der Fettsäuresynthase (FASN) konzentrieren und insbesondere den differenzierten Wirkmechanismus von Denifanstat sowie dessen antifibrotische Effekte, die in der Phase-2b-Studie FASCINATE-2 bei MASH-Patienten der Stadien F2/F3 beobachtet wurden, hervorheben.
Dr. Marie O'Farrell, SVP für Forschung und Entwicklung bei Sagimet, wird während der Sitzung 4: Das Versprechen neuer pharmakologischer Wirkstoffe + Pathophysiologie präsentieren. Denifanstat, der Hauptkandidaten von Sagimet, ist ein oraler FASN-Inhibitor, der einmal täglich eingenommen wird und von der FDA den Status einer Durchbruchtherapie zur Behandlung von nicht-zirrhotischem MASH mit mäßiger bis fortgeschrittener Leberfibrose erhalten hat. Nach den erfolgreichen Ergebnissen der Phase 2b und den Interaktionen mit der FDA am Ende der Phase 2 wird das Medikament in die Phase-3-Entwicklung übergehen.
- Denifanstat received FDA Breakthrough Therapy designation for MASH treatment
- Successful completion of Phase 2b FASCINATE-2 trial with positive results
- FDA end-of-Phase 2 interactions completed successfully, clearing path to Phase 3
- None.
SAN MATEO, Calif., Jan. 06, 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 an oral presentation highlighting fatty acid synthase (FASN) inhibitors will be given at the upcoming 9th Annual MASH-TAG Conference being held January 9-11, 2025 in Park City, Utah. The presentation will focus on the differentiated mechanism of action of the FASN inhibitor denifanstat and the observed anti-fibrotic effect in the Phase 2b FASCINATE-2 study in F2/F3 MASH.
MASH-TAG 2025 Presentation Details:
| Title: | FASN Inhibitors |
| Presenter: | Marie O’Farrell, Ph.D. (SVP of Research and Development, Sagimet Biosciences) |
| Session: | Session 4: The Promise of New Pharmacological Agents + Pathophysiology |
| Date/Time: | Friday, January 10, 2025 at 6:10 PM MST |
| Location: | The Chateaux Deer Valley, Park City, Utah |
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 to improve diagnostic clarity.
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; 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 Sagimet's (SGMT) FASCINATE-2 Phase 2b trial for denifanstat?
When will Sagimet (SGMT) present their FASN inhibitor data at MASH-TAG 2025?
What FDA designation has Sagimet's (SGMT) denifanstat received for MASH treatment?
What is the current development stage of Sagimet's (SGMT) denifanstat?
