Ascletis Completes Enrollment of Phase III Trial of ASC40 (Denifanstat) Once-Daily Oral Tablet for Treatment of Acne
Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial of ASC40 (denifanstat), a once-daily oral tablet for treating moderate to severe acne. The randomized, double-blind, placebo-controlled trial began on January 24, 2024, with patients divided equally between treatment and placebo groups. The study will evaluate 50 mg ASC40 over 12 weeks, with topline results expected in Q2 2025.
ASC40 is a first-in-class FASN inhibitor that works by inhibiting facial sebum production and reducing inflammation. The Phase II trial previously met primary and secondary endpoints with 19.4% of patients achieving treatment success versus 5.1% for placebo.
Ascletis Pharma ha completato l'arruolamento di 480 pazienti nel suo studio clinico di fase III su ASC40 (denifanstat), una compressa orale da assumere una volta al giorno per il trattamento dell'acne da moderata a grave. Lo studio randomizzato, in doppio cieco e controllato con placebo è iniziato il 24 gennaio 2024, con pazienti suddivisi equamente tra i gruppi di trattamento e placebo. La ricerca valuterà 50 mg di ASC40 per 12 settimane, con risultati preliminari attesi nel secondo trimestre del 2025.
ASC40 è un inibitore FASN di prima classe che agisce inibendo la produzione di sebo facciale e riducendo l'infiammazione. La fase II dello studio ha già raggiunto obiettivi primari e secondari, con il 19,4% dei pazienti che ha ottenuto successo nel trattamento rispetto al 5,1% del gruppo placebo.
Ascletis Pharma ha completado la inscripción de 480 pacientes en su ensayo clínico de fase III con ASC40 (denifanstat), un comprimido oral para tomar una vez al día para el tratamiento de acné de moderado a grave. El ensayo, aleatorizado, doble ciego y controlado con placebo, comenzó el 24 de enero de 2024, con pacientes divididos equitativamente entre los grupos de tratamiento y placebo. El estudio evaluará 50 mg de ASC40 durante 12 semanas, con resultados iniciales esperados para el segundo trimestre de 2025.
ASC40 es un inhibidor de FASN de primera clase que funciona inhibiendo la producción de sebo facial y reduciendo la inflamación. El ensayo de fase II ya cumplió con los objetivos primarios y secundarios, con un 19.4% de los pacientes logrando el éxito del tratamiento frente al 5.1% del grupo placebo.
Ascletis Pharma는 중등도에서 중증 여드름 치료를 위한 하루 한 번 복용하는 경구용 정제인 ASC40 (denifanstat)의 3상 임상 시험에 480명의 환자를 등록 완료했습니다. 이 무작위 이중 맹검, 위약 대조 시험은 2024년 1월 24일에 시작되었으며, 환자는 치료 그룹과 위약 그룹 간에 동등하게 나누어졌습니다. 연구에서는 12주 동안 50mg의 ASC40를 평가하며, 2025년 2분기에는 주요 결과가 예상됩니다.
ASC40는 얼굴 피지 생성을 억제하고 염증을 줄이는 방식으로 작용하는 첫 번째 세대 FASN 억제제입니다. 2상 임상 시험에서는 이미 1차 및 2차 목표를 충족하였으며, 치료 성공률이 19.4%로, 위약 그룹의 5.1%와 비교되었습니다.
Ascletis Pharma a terminé le recrutement de 480 patients dans son essai clinique de phase III sur ASC40 (denifanstat), un comprimé oral à prendre une fois par jour pour traiter l'acné modérée à sévère. L'essai randomisé, en double aveugle et contrôlé par placebo a commencé le 24 janvier 2024, les patients étant répartis également entre les groupes de traitement et de placebo. L'étude évaluera 50 mg d'ASC40 sur 12 semaines, avec des résultats préliminaires attendus au deuxième trimestre de 2025.
ASC40 est un inhibiteur de FASN de première classe qui agit en inhibant la production de sébum facial et en réduisant l'inflammation. L'essai de phase II a déjà atteint les objectifs primaires et secondaires, avec 19,4 % des patients atteignant un succès de traitement contre 5,1 % pour le groupe placebo.
Ascletis Pharma hat die Rekrutierung von 480 Patienten für seine Phase-III-Studie zu ASC40 (denifanstat) abgeschlossen, einer einmal täglich einzunehmenden Tablette zur Behandlung von moderater bis schwerer Akne. Die randomisierte, doppelblinde, placebo-kontrollierte Studie begann am 24. Januar 2024, wobei die Patienten gleichmäßig auf Behandlungs- und Placebogruppen verteilt wurden. Die Studie wird 50 mg ASC40 über 12 Wochen bewerten, wobei erste Ergebnisse im zweiten Quartal 2025 erwartet werden.
ASC40 ist ein erstklassiger FASN-Hemmer, der durch die Hemmung der Talgproduktion im Gesicht und die Reduzierung von Entzündungen wirkt. In der Phase-II-Studie wurden bereits primäre und sekundäre Endpunkte erreicht, wobei 19,4 % der Patienten einen Behandlungserfolg erzielten, verglichen mit 5,1 % in der Placebogruppe.
- Phase III trial successfully completed enrollment target of 480 patients
- Previous Phase II trial met primary and secondary endpoints with 19.4% treatment success vs 5.1% placebo
- Novel first-in-class drug mechanism with dual action on sebum production and inflammation
- Topline results not available until Q2 2025
- Phase II showed relatively low absolute treatment success rate of 19.4%
Insights
The completion of Phase III enrollment for ASC40 (denifanstat) marks a significant milestone in acne treatment development. The 480-patient trial is well-designed with proper randomization and controls, evaluating a novel mechanism of action through FASN inhibition. The previous Phase II results showing
The dual mechanism targeting both sebum production and inflammation through DNL inhibition represents an innovative approach. However, investors should note that the Q2 2025 timeline for topline results means a considerable wait before potential commercialization. The Chinese market focus also limits immediate global market potential, though success could lead to expanded trials internationally.
-Phase III trial enrolled a total of 480 patients with moderate to severe acne
-Topline results expected in the second quarter 2025
This Phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in
The primary efficacy endpoints are the proportion of patients achieving treatment success at week 12, the percentage change from baseline in total lesion count at week 12, and the percentage change from baseline in inflammatory lesion count at week 12. Treatment success is defined as at least a 2-point reduction in Investigator's Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear (1).
On May 2, 2023, Ascletis announced that the Phase II clinical trial for ASC40 once-daily oral tablet for the treatment of acne vulgaris met the primary and key secondary endpoints, demonstrating superior efficacy including
ASC40 is a first-in-class, once-daily oral, selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of ASC40 for treatment of acne are (1) direct inhibition of facial sebum production through inhibition of de novo lipogenesis (DNL) in human sebocytes, and (2) inhibition of inflammation through decreasing cytokine secretion and Th17 differentiation. ASC40 is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in
"As a first-in-class once-daily oral drug candidate with novel mechanism for acne treatment, ASC40 has shown positive efficacy and a good safety profile in the Phase II study. We look forward to announcing topline results of the ASC40 (denifanstat) Phase III trial in the second quarter 2025." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
About Ascletis Pharma Inc.
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis has rapidly advanced its pipeline, focusing on two therapeutic areas with unmet medical needs from a global perspective: metabolic diseases and viral diseases. Ascletis has multiple clinical stage drug candidates in its R&D pipeline.
For more information, please visit www.ascletis.com.
Contact：
Peter Vozzo
ICR Healthcare
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Peter.vozzo@westwicke.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (
pr@ascletis.com
ir@ascletis.com
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SOURCE Ascletis Pharma Inc.
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