Sagimet Biosciences to Host Virtual KOL Event, “Evaluating the Synergistic Potential of a Combination of Denifanstat and Resmetirom for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)” on May 29, 2025
Sagimet Biosciences (NASDAQ: SGMT) announced a virtual KOL event scheduled for May 29, 2025, focusing on the potential combination therapy of denifanstat and resmetirom for treating advanced Metabolic Dysfunction-Associated Steatohepatitis (MASH). The event will feature Dr. Rohit Loomba from UC San Diego and company management discussing the planned Phase 1 pharmacokinetic trial of this combination.
The development strategy builds on successful Phase 2b FASCINATE-2 trial results of denifanstat in MASH F2-F3 patients and preclinical data showing synergistic effects when combining FASN inhibitors with resmetirom. Preclinical studies presented at EASL 2024 demonstrated that the combination improved liver disease markers more effectively than single agents, including better NAS scores and hepatic collagen content improvements.
Denifanstat, Sagimet's lead candidate, is an oral, daily FASN inhibitor that may complement resmetirom's fat oxidizer properties in treating MASH patients.
Sagimet Biosciences (NASDAQ: SGMT) ha annunciato un evento virtuale KOL previsto per il 29 maggio 2025, incentrato sulla potenziale terapia combinata di denifanstat e resmetirom per il trattamento della Steatoepatite Metabolica Associata a Disfunzione (MASH) in fase avanzata. L'evento vedrà la partecipazione del Dr. Rohit Loomba dell'UC San Diego e del management aziendale, che discuteranno il trial farmacocinetico di Fase 1 pianificato per questa combinazione.
La strategia di sviluppo si basa sui risultati positivi del trial di Fase 2b FASCINATE-2 su denifanstat in pazienti con MASH F2-F3 e su dati preclinici che mostrano effetti sinergici combinando inibitori FASN con resmetirom. Studi preclinici presentati all'EASL 2024 hanno dimostrato che la combinazione migliora i marcatori della malattia epatica più efficacemente rispetto ai singoli farmaci, con miglioramenti nei punteggi NAS e nel contenuto di collagene epatico.
Denifanstat, il candidato principale di Sagimet, è un inibitore orale giornaliero di FASN che potrebbe integrare le proprietà ossidanti dei grassi di resmetirom nel trattamento dei pazienti con MASH.
Sagimet Biosciences (NASDAQ: SGMT) anunció un evento virtual KOL programado para el 29 de mayo de 2025, centrado en la posible terapia combinada de denifanstat y resmetirom para tratar la Esteatohepatitis Asociada a Disfunción Metabólica (MASH) avanzada. El evento contará con la participación del Dr. Rohit Loomba de UC San Diego y la dirección de la empresa, quienes discutirán el ensayo farmacocinético de Fase 1 planeado para esta combinación.
La estrategia de desarrollo se basa en los exitosos resultados del ensayo FASCINATE-2 de Fase 2b con denifanstat en pacientes con MASH F2-F3 y en datos preclínicos que muestran efectos sinérgicos al combinar inhibidores de FASN con resmetirom. Estudios preclínicos presentados en EASL 2024 demostraron que la combinación mejoró los marcadores de la enfermedad hepática más eficazmente que los agentes individuales, incluyendo mejores puntuaciones NAS y mejoras en el contenido de colágeno hepático.
Denifanstat, el candidato principal de Sagimet, es un inhibidor oral diario de FASN que podría complementar las propiedades oxidantes de grasas de resmetirom en el tratamiento de pacientes con MASH.
Sagimet Biosciences (NASDAQ: SGMT)는 2025년 5월 29일에 진행될 예정인 가상 KOL 이벤트를 발표했으며, 고도 진행된 대사 기능 장애 연관 지방간염(MASH) 치료를 위한 데니판스타트와 레스메티롬의 병용 요법 가능성에 중점을 둡니다. 이번 행사에는 UC 샌디에이고의 로히트 룸바 박사와 회사 경영진이 참석하여 이 병용 요법의 1상 약동학 시험 계획에 대해 논의할 예정입니다.
개발 전략은 MASH F2-F3 환자를 대상으로 한 데니판스타트의 2b상 FASCINATE-2 시험 성공 결과와 FASN 억제제와 레스메티롬 병용 시 시너지 효과를 보여준 전임상 데이터를 기반으로 합니다. 2024년 EASL에서 발표된 전임상 연구들은 이 병용 요법이 단독 약물보다 간 질환 지표를 더 효과적으로 개선하며, NAS 점수와 간 콜라겐 함량 개선에서 우수함을 입증했습니다.
데니판스타트는 Sagimet의 주요 후보 물질로, 매일 경구 복용하는 FASN 억제제로서 MASH 환자 치료에 있어 레스메티롬의 지방 산화 작용을 보완할 수 있습니다.
Sagimet Biosciences (NASDAQ : SGMT) a annoncé un événement virtuel KOL prévu pour le 29 mai 2025, axé sur la thérapie combinée potentielle de denifanstat et resmetirom pour le traitement de la stéatohépatite associée à une dysfonction métabolique (MASH) avancée. L'événement réunira le Dr Rohit Loomba de l'UC San Diego et la direction de l'entreprise pour discuter de l'essai pharmacocinétique de phase 1 prévu pour cette combinaison.
La stratégie de développement s'appuie sur les résultats positifs de l'essai de phase 2b FASCINATE-2 de denifanstat chez des patients MASH F2-F3 et sur des données précliniques montrant des effets synergiques lors de la combinaison d'inhibiteurs de FASN avec le resmetirom. Des études précliniques présentées à l'EASL 2024 ont démontré que la combinaison améliorait plus efficacement les marqueurs de la maladie hépatique que les agents seuls, notamment avec de meilleurs scores NAS et une amélioration du contenu en collagène hépatique.
Denifanstat, le candidat principal de Sagimet, est un inhibiteur oral quotidien de FASN qui pourrait compléter les propriétés oxydantes des graisses du resmetirom dans le traitement des patients atteints de MASH.
Sagimet Biosciences (NASDAQ: SGMT) kündigte eine virtuelle KOL-Veranstaltung für den 29. Mai 2025 an, die sich auf die potenzielle Kombinationstherapie mit Denifanstat und Resmetirom zur Behandlung der fortgeschrittenen Metabolisch bedingten Steatohepatitis (MASH) konzentriert. Bei der Veranstaltung werden Dr. Rohit Loomba von der UC San Diego und das Management des Unternehmens die geplante Phase-1-Pharmakokinetik-Studie dieser Kombination besprechen.
Die Entwicklungsstrategie baut auf den erfolgreichen Ergebnissen der Phase-2b-Studie FASCINATE-2 mit Denifanstat bei MASH-Patienten im Stadium F2-F3 sowie auf präklinischen Daten auf, die synergistische Effekte bei der Kombination von FASN-Inhibitoren mit Resmetirom zeigen. Präklinische Studien, die auf der EASL 2024 vorgestellt wurden, zeigten, dass die Kombination die Lebererkrankungsmarker effektiver verbesserte als Einzelwirkstoffe, einschließlich besserer NAS-Werte und Verbesserungen des hepatischen Kollagengehalts.
Denifanstat, der führende Kandidat von Sagimet, ist ein oral täglich einzunehmender FASN-Inhibitor, der die fettverbrennenden Eigenschaften von Resmetirom bei der Behandlung von MASH-Patienten ergänzen könnte.
- None.
- None.
SAN MATEO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Thursday, May 29, 2025 at 1:00 PM ET. To register, click here.
The event will feature Rohit Loomba, MD, MHSc (Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego), who will join company management to discuss the potential for developing a combination of denifanstat, a fat synthesis inhibitor, with a fat oxidizer, such as resmetirom, a thyroid hormone beta receptor agonist, to treat advanced metabolic dysfunction-associated steatohepatitis (MASH). The planned development program builds upon the successful results of the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients, as well as on preclinical data demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers.
The event will provide an overview of the planned Phase 1 pharmacokinetic clinical trial of the denifanstat and resmetirom combination, and a discussion on the potential benefits of combination therapy to treat patients living with advanced MASH. Denifanstat, Sagimet's lead product candidate, is an oral, once daily selective fatty acid synthase (FASN) inhibitor in development for the treatment of MASH, whose strong anti-fibrotic mechanism of action coupled with its inhibition of liver fat synthesis may be complementary to a fat oxidizer molecule such as resmetirom. Pre-clinical data presented at EASL in 2024 for two mouse models of MASH showed that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and resmetirom had a synergistic effect on important markers of liver disease, including improvement of NAS (NAFLD Activity Score) by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents.
A live question and answer session will follow the formal presentations. A replay of this event will be available in the Investors & Media section of Sagimet’s website at www.sagimet.com for 90 days following the live event.
About Rohit Loomba, MD, MHSc
Rohit Loomba, MD, MHSc is a board-certified gastroenterologist and serves as the Chief, Division of Gastroenterology and Hepatology at University of California at San Diego. He is also the founding director of the UCSD MASLD Research Center. His expertise includes treating and managing many types of chronic liver disease, such as metabolic dysfunction-associated steatotic liver disease (MASLD), nonalcoholic steatohepatitis, chronic hepatitis, cirrhosis, and hemochromatosis. As a transplant hepatologist, Dr. Loomba works with transplant surgeons in the pre and postoperative care of liver transplant patients. As a professor in the Division of Gastroenterology, Dr. Loomba instructs students, residents and fellows in the Department of Medicine at UC San Diego School of Medicine. His research focuses on all aspects of MASLD, including prevalence in aging, epidemiology, genetic and environmental predisposition and progression. Dr. Loomba is the founding director of the UCSD MASLD Research Center where a multi-disciplinary team of researchers are conducting cutting edge research in all aspects of MASLD including non-invasive biomarkers, genetics, epidemiology, clinical trial design, imaging end-points, and integrated OMICs using microbiome, metabolome and lipidome. This integrated approach has led to several innovative applications such as establishment of MRI-PDFF as a non-invasive biomarker of treatment response in early phase trials in MASH, which has now been adopted in more than a hundred clinical trials conducted worldwide. He holds several patents on non-invasive biomarkers of MASH and fibrosis. His research is funded by the National Institutes of Health as a Principal Investigator including two R01s, three U01 (two NIDDK and one from NIAAA), clinical core director of P30 (NIDDK) and project director P01 (NHLBI) grant mechanisms, Foundation of NIH, as well as several large multicenter, multi-million dollar investigator initiated research projects funded by the industry. He is the Principal Investigator, UCSD, for the NIDDK-sponsored MASH Clinical Research Network and the Liver Cirrhosis Network. Dr. Loomba has published more than 500 peer-reviewed manuscripts in his field. He is an elected member of the American Society of Clinical Investigation and the Association of American Physicians.
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 further development. Sagimet’s second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial for a potential acne indication. 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; 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.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Michael Fitzhugh
LifeSci Advisors
mfitzhugh@lifescicomms.com
FAQ
What is the purpose of Sagimet Biosciences' (SGMT) upcoming KOL event on May 29, 2025?
What were the preclinical results of combining denifanstat with resmetirom for MASH treatment?
What is denifanstat and how does it work in MASH treatment?
What were the results of the FASCINATE-2 trial for SGMT's denifanstat?
