Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne
Sagimet Biosciences (NASDAQ: SGMT) has received IND clearance for TVB-3567, its second fatty acid synthase (FASN) inhibitor, targeting acne treatment. The company plans to initiate a first-in-human Phase 1 clinical trial in 2025.
TVB-3567 is a potent and selective small molecule FASN inhibitor designed to treat acne by targeting sebum production. The planned Phase 1 trial will be a randomized double-blind placebo-controlled study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants with or without acne.
The development builds on promising data from their denifanstat program, which showed favorable sebum lipid composition changes in Phase 1 and significant decreases in acne lesions in a Phase 2 trial conducted by license partner Ascletis BioScience in China. With over 50 million people suffering from acne in the US, FASN inhibition represents a significant commercial opportunity, as it targets the production of approximately 80% of sebum lipids.
Sagimet Biosciences (NASDAQ: SGMT) ha ricevuto l'autorizzazione IND per TVB-3567, il suo secondo inibitore della sintasi degli acidi grassi (FASN), mirato al trattamento dell'acne. L'azienda prevede di avviare un primo studio clinico di fase 1 su esseri umani nel 2025.
TVB-3567 è un potente e selettivo inibitore della sintasi degli acidi grassi progettato per trattare l'acne agendo sulla produzione di sebo. Lo studio di fase 1 pianificato sarà uno studio randomizzato, in doppio cieco e controllato con placebo, volto a valutare la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica in partecipanti sani con o senza acne.
Lo sviluppo si basa su dati promettenti del loro programma denifanstat, che ha mostrato cambiamenti favorevoli nella composizione lipidica del sebo in fase 1 e significative riduzioni delle lesioni acneiche in uno studio di fase 2 condotto dal partner di licenza Ascletis BioScience in Cina. Con oltre 50 milioni di persone che soffrono di acne negli Stati Uniti, l'inibizione della FASN rappresenta un'importante opportunità commerciale, poiché mira alla produzione di circa l'80% dei lipidi del sebo.
Sagimet Biosciences (NASDAQ: SGMT) ha recibido la aprobación IND para TVB-3567, su segundo inhibidor de la sintasa de ácidos grasos (FASN), dirigido al tratamiento del acné. La compañía planea iniciar un ensayo clínico de fase 1 en humanos en 2025.
TVB-3567 es una molécula pequeña potente y selectiva que actúa como inhibidor de FASN, diseñada para tratar el acné al atacar la producción de sebo. El ensayo de fase 1 planeado será un estudio aleatorizado, doble ciego y controlado con placebo que evaluará la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica en participantes sanos con o sin acné.
El desarrollo se basa en datos prometedores de su programa denifanstat, que mostró cambios favorables en la composición lipídica del sebo en fase 1 y disminuciones significativas en las lesiones de acné en un ensayo de fase 2 realizado por el socio de licencia Ascletis BioScience en China. Con más de 50 millones de personas sufriendo de acné en los EE. UU., la inhibición de FASN representa una oportunidad comercial significativa, ya que apunta a la producción de aproximadamente el 80% de los lípidos del sebo.
사기멧 바이오사이언스 (NASDAQ: SGMT)는 여드름 치료를 목표로 하는 두 번째 지방산 합성효소 (FASN) 억제제 TVB-3567에 대한 IND 승인을 받았습니다. 이 회사는 2025년에 인간을 대상으로 한 1상 임상 시험을 시작할 계획입니다.
TVB-3567은 피지 생성을 타겟으로 하여 여드름을 치료하기 위해 설계된 강력하고 선택적인 소분자 FASN 억제제입니다. 계획된 1상 시험은 여드름이 있는 건강한 참가자와 없는 참가자를 대상으로 안전성, 내약성, 약동학 및 약력학을 평가하는 무작위 이중 맹검 위약 대조 연구가 될 것입니다.
이 개발은 중국의 라이센스 파트너인 아스클레티스 바이오사이언스가 수행한 2상 시험에서 여드름 병변의 유의미한 감소를 보여준 데니판스타트 프로그램의 유망한 데이터를 기반으로 합니다. 미국에서 5000만 명 이상의 사람들이 여드름으로 고통받고 있는 가운데, FASN 억제는 약 80%의 피지 지질 생성을 겨냥하기 때문에 중요한 상업적 기회를 제공합니다.
Sagimet Biosciences (NASDAQ: SGMT) a reçu l'autorisation IND pour TVB-3567, son deuxième inhibiteur de la synthase des acides gras (FASN), visant à traiter l'acné. L'entreprise prévoit de lancer un essai clinique de phase 1 sur des humains en 2025.
TVB-3567 est un inhibiteur de la FASN, puissant et sélectif, conçu pour traiter l'acné en ciblant la production de sébum. L'essai de phase 1 prévu sera une étude randomisée, en double aveugle et contrôlée par placebo, visant à évaluer la sécurité, la tolérance, la pharmacocinétique et la pharmacodynamique chez des participants sains, avec ou sans acné.
Le développement s'appuie sur des données prometteuses de leur programme denifanstat, qui a montré des changements favorables dans la composition lipidique du sébum en phase 1 et des diminutions significatives des lésions d'acné lors d'un essai de phase 2 réalisé par le partenaire de licence Ascletis BioScience en Chine. Avec plus de 50 millions de personnes souffrant d'acné aux États-Unis, l'inhibition de la FASN représente une opportunité commerciale significative, car elle cible la production d'environ 80 % des lipides du sébum.
Sagimet Biosciences (NASDAQ: SGMT) hat die IND-Zulassung für TVB-3567, seinen zweiten Inhibitor der Fettsäuresynthase (FASN), erhalten, der auf die Behandlung von Akne abzielt. Das Unternehmen plant, 2025 eine erste klinische Phase-1-Studie am Menschen zu starten.
TVB-3567 ist ein potenter und selektiver kleiner Molekül-FASN-Inhibitor, der entwickelt wurde, um Akne zu behandeln, indem die Talgproduktion angegriffen wird. Die geplante Phase-1-Studie wird eine randomisierte, doppelblinde, placebo-kontrollierte Studie sein, die Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik bei gesunden Teilnehmern mit oder ohne Akne bewertet.
Die Entwicklung baut auf vielversprechenden Daten aus ihrem Denifanstat-Programm auf, das in der Phase 1 günstige Veränderungen in der lipidischen Zusammensetzung des Talgs zeigte und signifikante Rückgänge von Akne-Läsionen in einer Phase-2-Studie, die von ihrem Lizenzpartner Ascletis BioScience in China durchgeführt wurde. Mit über 50 Millionen Menschen, die in den USA an Akne leiden, stellt die FASN-Hemmung eine bedeutende kommerzielle Gelegenheit dar, da sie die Produktion von etwa 80 % der Talglipide angreift.
- IND clearance received for second FASN inhibitor TVB-3567
- Expansion into dermatology market with 50M+ potential patients in US
- Previous positive clinical data from denifanstat program supports development
- Phase 2 trial showed significant reduction in acne lesions
- Phase 1 trials not starting until 2025
- Early-stage development with no guaranteed success
- Will require extensive clinical trials before potential commercialization
Insights
Sagimet's FDA IND clearance for TVB-3567 represents a significant milestone in acne treatment development. The FASN inhibition mechanism addresses acne at its root by targeting sebum production - the most significant contributor to acne pathogenesis. This approach is scientifically compelling as FASN produces approximately 80% of sebum lipids, including palmitate and sapienate.
The company's development strategy builds on encouraging clinical evidence: their previous FASN inhibitor (denifanstat) already demonstrated favorable sebum composition changes in Phase 1 trials, while their partner Ascletis showed significant reductions in both inflammatory and non-inflammatory acne lesions after 12 weeks in a Phase 2 trial in China.
With over 50 million acne sufferers in the US alone, the market opportunity is substantial. The planned Phase 1 trial design is comprehensive, including single and multiple ascending dose assessments in healthy participants followed by acne patient testing with biomarker evaluation to demonstrate mechanism proof.
This expansion into dermatology represents a logical therapeutic extension of Sagimet's FASN inhibitor platform. While still early-stage, the previous clinical validation of the mechanism increases confidence in the development pathway compared to entirely novel approaches.
The TVB-3567 IND clearance represents strategic pipeline expansion for Sagimet beyond their initial focus area. By leveraging their FASN inhibitor platform technology into dermatology, the company demonstrates smart portfolio diversification while maintaining technological cohesion.
Several aspects make this development particularly noteworthy:
- This marks Sagimet's second clinical-stage asset, reducing the company's binary risk profile compared to single-asset biotechs
- The acne indication offers accelerated development potential with well-defined endpoints and shorter trials compared to many other conditions
- Their approach targets a fundamental biological driver of acne (sebum production) rather than just symptoms
- The reference to previous human data from both their own Phase 1 and a partner's Phase 2 trial provides increased confidence in the mechanism
For a clinical-stage company with a
The planned first-in-human study starting in 2025 will provide important safety data and initial insights into the drug's effects on sebum production biomarkers. Positive results would further validate the company's platform technology and development capabilities.
TVB-3567 is the Company’s second fatty acid synthase (FASN) inhibitor
First-in-human Phase 1 trial initiation planned in 2025
SAN MATEO, Calif., March 11, 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 the clearance of its Investigational New Drug (IND) application for TVB-3567, the Company’s second fatty acid synthase (FASN) inhibitor. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. The IND with the U.S. Food and Drug Administration’s Division of Dermatology and Dentistry allows the Company to initiate a first-in-human Phase 1 clinical trial of TVB-3567, planned in 2025.
“The clearance of the TVB-3567 IND marks a significant milestone for Sagimet, as we advance our second FASN inhibitor into the clinic and expand our therapeutic presence into dermatology,” said David Happel, Chief Executive Officer of Sagimet. “FASN inhibition is a highly attractive target in the treatment of acne, addressing acne’s most significant contributor, sebum. We are excited about bringing TVB-3567 into the clinic, building upon compelling data from the denifanstat program in acne, including the favorable sebum lipid composition changes demonstrated in the Phase 1 clinical trial conducted by Sagimet, and the significant decreases in inflammatory and non-inflammatory lesion counts after 12 weeks of treatment shown in a Phase 2 clinical trial conducted by our license partner Ascletis BioScience in patients with moderate to severe acne vulgaris in China. Based on both its mechanism of action and strong preclinical profile, we believe TVB-3567 has the potential to offer a differentiated treatment option for acne. We look forward to initiating enrollment of the first-in-human study of TVB-3567 in 2025.”
Over 50 million people suffer from acne in the US, making it one of the most prevalent skin diseases that physicians address annually. Acne’s pathogenesis is highly associated with increased sebum production in the skin. FASN is the last committed step in the de novo lipogenesis pathway which produces approximately
The planned Phase 1 clinical trial will be a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is expected to be comprised of several parts, including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers.
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.
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
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