Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH
Sagimet Biosciences Inc. (Nasdaq: SGMT) announced that the FDA has granted Breakthrough Therapy designation to denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This designation was supported by positive data from the Phase 2b FASCINATE-2 trial, where denifanstat showed statistically significant improvements in MASH resolution and fibrosis reduction. The company plans to initiate a Phase 3 clinical program for denifanstat in MASH by the end of 2024.
Denifanstat, as the only fat synthesis inhibitor targeting the three main drivers of MASH (fat accumulation, inflammation, and fibrosis), demonstrated efficacy in meeting primary and secondary endpoints in the trial. The treatment was generally well-tolerated, positioning it as a potential leading treatment option for MASH patients.
Sagimet Biosciences Inc. (Nasdaq: SGMT) ha annunciato che la FDA ha concesso la designazione di Terapia Innovativa a denifanstat per il trattamento della steatoepatite metabolica associata a disfunzione non cirrotica (MASH) con fibrosi epatica da moderata ad avanzata. Questa designazione è stata supportata da dati positivi provenienti dallo studio clinico di Fase 2b FASCINATE-2, in cui denifanstat ha mostrato miglioramenti statisticamente significativi nella risoluzione del MASH e nella riduzione della fibrosi. L'azienda prevede di avviare un programma clinico di Fase 3 per denifanstat in MASH entro la fine del 2024.
Denifanstat, essendo l'unico inibitore della sintesi dei grassi che mira ai tre principali fattori scatenanti del MASH (accumulo di grassi, infiammazione e fibrosi), ha dimostrato efficacia nel raggiungere gli obiettivi primari e secondari nello studio. Il trattamento è stato generalmente ben tollerato, posizionandolo come una potenziale opzione terapeutica leader per i pazienti con MASH.
Sagimet Biosciences Inc. (Nasdaq: SGMT) anunció que la FDA ha otorgado la designación de Terapia Innovadora a denifanstat para el tratamiento de la esteatohepatitis asociada a disfunción metabólica no cirrótica (MASH) con fibrosis hepática moderada a avanzada. Esta designación fue respaldada por datos positivos del ensayo clínico de Fase 2b FASCINATE-2, donde denifanstat mostró mejoras estadísticamente significativas en la resolución de MASH y la reducción de la fibrosis. La empresa planea iniciar un programa clínico de Fase 3 para denifanstat en MASH para finales de 2024.
Denifanstat, como el único inhibidor de síntesis de grasas que se dirige a los tres principales impulsores del MASH (acumulación de grasa, inflamación y fibrosis), demostró eficacia en el cumplimiento de los objetivos primarios y secundarios en el ensayo. El tratamiento fue generalmente bien tolerado, posicionándolo como una posible opción de tratamiento líder para los pacientes con MASH.
사기멧 바이오사이언스 주식회사(Nasdaq: SGMT)는 FDA가 중간에서 진행된 간섬유증을 동반한 비간경변성 대사장애 연관 지방간염(MASH) 치료를 위해 denifanstat에 획기적인 치료제 지정을 부여했다고 발표했습니다. 이 지정은 denifanstat이 MASH 해결과 섬유증 감소에서 통계적으로 유의미한 개선을 보였던 2b상 FASCINATE-2 시험의 긍정적인 데이터에 의해 지원되었습니다. 회사는 2024년 말까지 MASH에서 denifanstat을 위한 3상 임상 프로그램을 시작할 계획입니다.
Denifanstat은 MASH의 세 가지 주요 원인(지방 축적, 염증 및 섬유증)을 목표로 하는 유일한 지방 합성 억제제로서, 시험에서 주요 및 부차적 과제를 충족하는 효능을 입증했습니다. 이 치료법은 일반적으로 잘 견뎌졌으며, MASH 환자들을 위한 잠재적인 주도적 치료 옵션으로 자리 잡고 있습니다.
Sagimet Biosciences Inc. (Nasdaq: SGMT) a annoncé que la FDA avait accordé la dénomination de Thérapie Innovante à denifanstat pour le traitement de la stéatohépatite associée à une dysfonction métabolique non cirrhotique (MASH) avec fibrose hépatique modérée à avancée. Cette désignation a été soutenue par des données positives de l'essai clinique de Phase 2b FASCINATE-2, où denifanstat a montré des améliorations statistiquement significatives dans la résolution du MASH et la réduction de la fibrose. L'entreprise prévoit de démarrer un programme clinique de Phase 3 pour denifanstat dans le MASH d'ici la fin de 2024.
Denifanstat, en tant que seul inhibiteur de la synthèse des graisses ciblant les trois principaux moteurs du MASH (accumulation de graisse, inflammation et fibrose), a démontré son efficacité à atteindre les objectifs principaux et secondaires dans l'essai. Le traitement a généralement été bien toléré, le positionnant comme une option thérapeutique potentielle de premier plan pour les patients atteints de MASH.
Sagimet Biosciences Inc. (Nasdaq: SGMT) hat angekündigt, dass die FDA die Breakthrough-Therapie-Bezeichnung für denifanstat zur Behandlung der nicht-zirrhotischen, metabolisch bedingten fettigen Leberentzündung (MASH) mit moderater bis fortgeschrittener Leberfibrose erteilt hat. Diese Bezeichnung wurde durch positive Daten aus der Phase-2b-Studie FASCINATE-2 unterstützt, in der denifanstat statistisch signifikante Verbesserungen bei der MASH-Resorption und der Fibrose-Reduktion zeigte. Das Unternehmen plant, bis Ende 2024 ein Phase-3-Studienprogramm für denifanstat in der Behandlung von MASH zu beginnen.
Denifanstat, als der einzige Hemmstoff der Fettsynthese, der die drei Hauptursachen von MASH (Fettansammlung, Entzündung und Fibrose) anspricht, zeigte in der Studie eine Wirksamkeit in Bezug auf die primären und sekundären Endpunkte. Die Behandlung wurde allgemein gut vertragen, was sie als potenzielle führende Behandlungsoption für MASH-Patienten positioniert.
- FDA granted Breakthrough Therapy designation for denifanstat in MASH treatment
- Positive Phase 2b trial results showing statistically significant improvements in MASH resolution and fibrosis reduction
- Denifanstat met both primary endpoints and key secondary endpoints in the FASCINATE-2 trial
- Plans to initiate Phase 3 clinical program by the end of 2024
- Denifanstat was generally well-tolerated in the Phase 2b trial
- None.
Insights
The FDA's Breakthrough Therapy designation for denifanstat is a significant milestone for Sagimet Biosciences. This designation, based on positive Phase 2b FASCINATE-2 trial results, accelerates the development and review process for denifanstat in treating noncirrhotic MASH with moderate to advanced liver fibrosis.
Key points to consider:
- Denifanstat is the only fat synthesis inhibitor targeting all three main MASH drivers: fat accumulation, inflammation and fibrosis.
- The Phase 2b trial showed statistically significant improvements in MASH resolution and fibrosis reduction.
- The drug met both FDA-recommended histology endpoints for accelerated approval in MASH.
- Sagimet plans to initiate Phase 3 trials by the end of 2024, potentially fast-tracking the drug's path to market.
This news positions Sagimet favorably in the competitive MASH treatment landscape, potentially leading to increased investor interest and market value. However, success in Phase 3 trials and eventual FDA approval will be important for long-term growth.
This Breakthrough Therapy designation significantly enhances Sagimet's market position and potential financial outlook. Key financial implications include:
- Accelerated development: Faster FDA review could lead to earlier market entry, potentially increasing the drug's lifetime revenue.
- Cost savings: Intensive FDA guidance may reduce development costs and timelines.
- Market advantage: Being first-to-market or among the first treatments for MASH could capture significant market share.
- Increased valuation: This news may positively impact Sagimet's stock price and attract more investor interest.
- Partnership potential: The designation could make Sagimet an attractive partner for larger pharmaceutical companies, potentially leading to lucrative deals.
With a market cap of
Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH
Preparations are ongoing to initiate Phase 3 program for denifanstat by the end of 2024
SAN MATEO, Calif., Oct. 01, 2024 (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 the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
“The FDA’s Breakthrough Therapy designation for denifanstat underscores the global incidence of MASH and the continuing need for new therapies,” said David Happel, Chief Executive Officer of Sagimet. “As the only fat synthesis inhibitor that directly targets the three main drivers of MASH— fat accumulation, inflammation, and fibrosis— we believe denifanstat is well-positioned to offer a leading treatment option for patients living with MASH.”
Treatments that receive Breakthrough Therapy designation must target a serious or life-threatening disease and preliminary clinical evidence must indicate that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive Breakthrough Therapy designation are eligible for all the benefits of Fast Track designation, as well as intensive guidance by FDA on an efficient drug development program and organizational commitment involving FDA senior managers.
Breakthrough Therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 clinical trial in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis. In the trial, denifanstat showed statistically significant improvements relative to placebo on both primary endpoints of MASH resolution without worsening of fibrosis with ≥2-point reduction in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS), and ≥2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of MASH, and a statistically significantly greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic 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 MASH. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.
About MASH
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; 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 is the Breakthrough Therapy designation granted to Sagimet's denifanstat (SGMT)?
What were the key results of Sagimet's (SGMT) Phase 2b FASCINATE-2 trial for denifanstat?
When does Sagimet (SGMT) plan to start the Phase 3 clinical program for denifanstat?
How does denifanstat differ from other MASH treatments according to Sagimet (SGMT)?
