e-therapeutics Presents New Data Supporting ETX‑312 as a Differentiated and Disease-Modifying Near-Clinic Treatment for MASH
e-therapeutics announced new preclinical results for ETX-312, their GalOmic siRNA candidate for treating metabolic dysfunction-associated steatohepatitis (MASH), to be presented at EASL Congress 2025. The study using the Gubra-Amylin NASH diet-induced obese mouse model showed that ETX-312 achieved:
- Significant improvements in NAFLD Activity Score (NAS), both as monotherapy and in combination therapy - All mice on combination therapy achieved ≥2-point NAS reductions, with up to 5-point improvements - Comparable fibrosis progression slowdown to GLP-1/GIP receptor agonist or FGF-21 analogue controls - Statistically significant reductions in hepatic collagen staining and biomarkers TIMP-1 and PIIINP
The company remains on track for regulatory submission by end of 2025, with ETX-312 currently in IND-enabling studies.
e-therapeutics ha annunciato nuovi risultati preclinici per ETX-312, il loro candidato GalOmic siRNA per il trattamento della steatoepatite associata a disfunzione metabolica (MASH), che saranno presentati al Congresso EASL 2025. Lo studio, condotto sul modello murino obeso indotto dalla dieta Gubra-Amylin NASH, ha dimostrato che ETX-312 ha ottenuto:
- Miglioramenti significativi nel punteggio di attività NAFLD (NAS), sia come monoterapia che in terapia combinata
- Tutti i topi sottoposti a terapia combinata hanno raggiunto una riduzione del NAS di ≥2 punti, con miglioramenti fino a 5 punti
- Rallentamento della progressione della fibrosi comparabile a quello ottenuto con agonisti del recettore GLP-1/GIP o analoghi FGF-21
- Riduzioni statisticamente significative nella colorazione del collagene epatico e nei biomarcatori TIMP-1 e PIIINP
L'azienda conferma di essere in linea con la tabella di marcia per la presentazione regolatoria entro la fine del 2025, con ETX-312 attualmente in studi per l'abilitazione IND.
e-therapeutics anunció nuevos resultados preclínicos para ETX-312, su candidato GalOmic siRNA para el tratamiento de la esteatohepatitis asociada a disfunción metabólica (MASH), que se presentarán en el Congreso EASL 2025. El estudio realizado en el modelo de ratón obeso inducido por dieta Gubra-Amylin NASH mostró que ETX-312 logró:
- Mejoras significativas en la puntuación de actividad de NAFLD (NAS), tanto en monoterapia como en terapia combinada
- Todos los ratones en terapia combinada lograron reducciones en NAS de ≥2 puntos, con mejoras de hasta 5 puntos
- Ralentización comparable de la progresión de la fibrosis en comparación con agonistas de los receptores GLP-1/GIP o análogos de FGF-21
- Reducciones estadísticamente significativas en la tinción de colágeno hepático y en los biomarcadores TIMP-1 y PIIINP
La compañía mantiene su plan para la presentación regulatoria a finales de 2025, con ETX-312 actualmente en estudios para habilitar la IND.
e-therapeutics는 대사 기능 장애 관련 지방간염(MASH) 치료를 위한 GalOmic siRNA 후보물질 ETX-312의 새로운 전임상 결과를 발표했으며, 이는 2025년 EASL 학회에서 발표될 예정입니다. Gubra-Amylin NASH 식이로 유도된 비만 마우스 모델을 사용한 연구에서 ETX-312는 다음과 같은 성과를 보였습니다:
- 단독요법과 병용요법 모두에서 NAFLD 활동 점수(NAS)의 유의미한 개선
- 병용요법을 받은 모든 마우스에서 NAS가 2점 이상 감소했으며 최대 5점까지 개선
- GLP-1/GIP 수용체 작용제 또는 FGF-21 유사체 대조군과 유사한 섬유증 진행 속도 감소
- 간 콜라겐 염색 및 생체지표 TIMP-1, PIIINP의 통계적으로 유의한 감소
회사는 2025년 말까지 규제 제출을 계획대로 진행 중이며, ETX-312는 현재 IND 승인 준비 연구 단계에 있습니다.
e-therapeutics a annoncé de nouveaux résultats précliniques pour ETX-312, leur candidat GalOmic siRNA destiné au traitement de la stéatohépatite associée à une dysfonction métabolique (MASH), qui seront présentés au Congrès EASL 2025. L'étude utilisant le modèle murin obèse induit par un régime Gubra-Amylin NASH a montré que ETX-312 a obtenu :
- Des améliorations significatives du score d'activité NAFLD (NAS), en monothérapie comme en thérapie combinée
- Tous les souris sous thérapie combinée ont obtenu une réduction du NAS de ≥2 points, avec des améliorations allant jusqu'à 5 points
- Un ralentissement de la progression de la fibrose comparable à celui des agonistes des récepteurs GLP-1/GIP ou des analogues du FGF-21
- Des réductions statistiquement significatives de la coloration du collagène hépatique et des biomarqueurs TIMP-1 et PIIINP
L'entreprise reste dans les temps pour une soumission réglementaire d'ici fin 2025, ETX-312 étant actuellement en études permettant l'IND.
e-therapeutics hat neue präklinische Ergebnisse für ETX-312, ihren GalOmic siRNA-Kandidaten zur Behandlung der metabolisch bedingten Steatohepatitis (MASH), bekannt gegeben, die auf dem EASL-Kongress 2025 vorgestellt werden. Die Studie mit dem Gubra-Amylin NASH diätinduzierten fettleibigen Mausmodell zeigte, dass ETX-312 folgende Ergebnisse erzielte:
- Signifikante Verbesserungen im NAFLD Activity Score (NAS), sowohl als Monotherapie als auch in Kombinationstherapie
- Bei allen Mäusen in der Kombinationstherapie wurde eine NAS-Reduktion von ≥2 Punkten erreicht, mit Verbesserungen von bis zu 5 Punkten
- Vergleichbare Verlangsamung der Fibroseprogression im Vergleich zu GLP-1/GIP-Rezeptoragonisten oder FGF-21-Analoga
- Statistisch signifikante Reduktionen der hepatischen Kollagenfärbung sowie der Biomarker TIMP-1 und PIIINP
Das Unternehmen bleibt im Zeitplan für die Zulassungseinreichung bis Ende 2025, wobei ETX-312 derzeit in IND-ermöglichenden Studien ist.
- Demonstrated significant improvements in NAFLD Activity Score (NAS) in preclinical trials
- Showed effectiveness both as monotherapy and in combination therapy
- Achieved comparable fibrosis progression slowdown to existing treatments
- On track for regulatory submission by end of 2025
- Still in preclinical stage, with clinical trials yet to begin
- Results limited to mouse model studies
LONDON, May 07, 2025 (GLOBE NEWSWIRE) -- e-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, today announced it will present new preclinical results on its GalOmic small‑interfering RNA (siRNA) candidate ETX‑312 for the treatment of metabolic dysfunction‑associated steatohepatitis (MASH) at the European Association for the Study of the Liver (EASL) Congress, 7th-10th May 2025.
In the leading Gubra‑Amylin NASH diet‑induced obese (GAN‑DIO) mouse model, ETX‑312 demonstrated:
- Dramatic improvements in NAFLD Activity Score (NAS) when administered as monotherapy or in combination with a GLP‑1/GIP receptor agonist or an FGF‑21 analogue. All mice receiving combination therapy achieved ≥ 2‑point reductions in NAS, with improvements of up to 5 points observed.
- Slowed fibrosis progression comparable to that achieved with GLP‑1/GIP receptor agonist or FGF‑21 analogue controls, supported by statistically significant reductions in hepatic collagen staining and in circulating biomarkers TIMP‑1 and PIIINP.
“These data add to a growing body of evidence supporting ETX-312 as a differentiated, disease-modifying therapy for MASH,” said Alan Whitmore, Chief Scientific Officer. “We are excited to progress the programme towards the clinic.”
ETX‑312 is currently in IND‑enabling studies, and the Company remains on track to submit a regulatory submission by the end of 2025.
Presentation Details
Title: ETX-312, a GalOmic siRNA for the treatment of MASH, effectively improves the MASH phenotype of GAN DIO-MASH mice alone or in combination with emerging therapies
Poster Number: FRI-337
Date: 9th May 2025
About ETX-312
ETX‑312 is a GalOmic GalNAc-conjugated small-interfering RNA (GalNAc-siRNA) therapeutic candidate in development to be a safe and effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) with potential for a quarterly subcutaneous dosing regimen. In preclinical studies using the Gubra-Amylin NASH diet-induced obese (GAN‑DIO) mouse model, administration of ETX-312 led to reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation, and slowed fibrosis progression, both as a monotherapy and in combination with emerging therapies. ETX-312 is currently progressing through IND-enabling studies, with a regulatory submission planned by the end of 2025.
About e-therapeutics plc
e-therapeutics plc ("ETX") uniquely combines computation and RNAi to discover and develop life-transforming medicines. ETX's proprietary RNAi chemistry platform, GalOmic™, enables generation of specific, potent, and durable siRNA therapeutics for effective silencing of novel gene targets in hepatocytes. The cutting-edge HepNet™ computational platform allows ETX to discover better medicines faster through generation of novel insights and increased automation across all stages of drug development. HepNet™ encompasses an extensive hepatocyte-specific knowledgebase and a suite of advanced AI-driven approaches which enable identification of novel gene targets, rapid target-indication assessment, and predictive in silico siRNA design. The Company has specialist expertise and a robust position in applying computation to biology. Its computational approaches have been extensively validated through generation of data from pipeline programs and successful drug discovery collaborations with biopharma companies, such as Novo Nordisk, Galapagos NV, and iTeos Therapeutics.
Leveraging the combined capabilities of HepNet™ and GalOmic™, ETX is progressing a therapeutic pipeline of highly differentiated RNAi candidates across a variety of therapeutic areas with high unmet need. The Company has generated positive proof-of-concept data on preclinical assets in metabolic dysfunction-associated steatohepatitis (MASH), dry age-related macular degeneration (dry AMD), haemophilia, heart failure, and cardiometabolic disease, further validating its computationally enhanced approach to research and development. ETX is currently progressing its GalOmic™ therapies towards the clinic with its most developed assets, ETX-312 for MASH, ETX-148 for bleeding disorders, and ETX-407 for dry AMD, at the IND-enabling stage.
Press Contact
press@etherapeutics.co.uk
Investor Relations Contact
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