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e-therapeutics De-risks Clinical Path for GalOmic Candidate ETX-312 with Positive Non-clinical Data

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e-therapeutics (OTCQX:ETXPF) has announced significant progress in de-risking its lead candidate ETX-312, a GalOmic siRNA therapy for metabolic dysfunction-associated steatohepatitis (MASH). The company has achieved two major milestones: successful completion of GLP-compliant toxicology studies showing excellent tolerability at high doses, and GMP manufacturing of the clinical trial batch.

The toxicology studies demonstrated that ETX-312 was well tolerated across all dose levels, with no toxicity or adverse findings, supporting a broad therapeutic window. The company remains on track for Clinical Trial Application (CTA) submission in Q4 2025, with productive regulatory interactions supporting their clinical strategy.

e-therapeutics (OTCQX:ETXPF) ha annunciato importanti progressi nella riduzione del rischio del suo candidato principale ETX-312, una terapia GalOmic siRNA per la steatoepatite associata a disfunzione metabolica (MASH). L'azienda ha raggiunto due traguardi fondamentali: il completamento con successo di studi tossicologici conformi a GLP che hanno evidenziato un'ottima tollerabilità a dosi elevate, e la produzione GMP del lotto destinato alla sperimentazione clinica.

Gli studi tossicologici hanno dimostrato che ETX-312 è stato ben tollerato a tutti i livelli di dosaggio, senza tossicità o effetti avversi, confermando un ampio margine terapeutico. L'azienda mantiene l'obiettivo di presentare la domanda di sperimentazione clinica (CTA) nel quarto trimestre del 2025, supportata da interazioni regolatorie efficaci che sostengono la strategia clinica.

e-therapeutics (OTCQX:ETXPF) ha anunciado avances significativos en la reducción de riesgos de su candidato principal ETX-312, una terapia GalOmic siRNA para la esteatohepatitis asociada a disfunción metabólica (MASH). La compañía ha alcanzado dos hitos importantes: la finalización exitosa de estudios toxicológicos conforme a GLP que mostraron una excelente tolerabilidad a dosis altas, y la fabricación GMP del lote para ensayos clínicos.

Los estudios toxicológicos demostraron que ETX-312 fue bien tolerado en todos los niveles de dosis, sin toxicidad ni hallazgos adversos, lo que respalda un amplio margen terapéutico. La empresa sigue en camino para la presentación de la Solicitud de Ensayo Clínico (CTA) en el cuarto trimestre de 2025, con interacciones regulatorias productivas que respaldan su estrategia clínica.

e-therapeutics (OTCQX:ETXPF)� 대� 기능 장애 연관 지방간�(MASH) 치료� 위한 GalOmic siRNA 치료제인 ETX-312� 위험 감소� 있어 중요� 진전� 발표했습니다. 회사� � 가지 주요 이정표를 달성했습니다: 고용량에� 우수� 내약성을 입증� GLP 준� 독성 연구� 성공� 완료와 임상 시험� 배치� GMP 제조입니�.

독성 연구 결과 ETX-312� 모든 투여량에� � 견뎌졌으�, 독성이나 부작용� 발견되지 않아 넓은 치료 범위� 뒷받침합니다. 회사� 2025� 4분기 임상시험 신청(CTA) 제출� 목표� 순조롭게 진행 중이�, 임상 전략� 지원하� 규제 당국과의 생산적인 소통� 이루어지� 있습니다.

e-therapeutics (OTCQX:ETXPF) a annoncé des progrès significatifs dans la réduction des risques de son candidat principal ETX-312, une thérapie siRNA GalOmic pour la stéato-hépatite associée à une dysfonction métabolique (MASH). L'entreprise a atteint deux étapes majeures : la réussite des études toxicologiques conformes aux normes GLP montrant une excellente tolérance à fortes doses, et la fabrication GMP du lot destiné à l'essai clinique.

Les études toxicologiques ont démontré que ETX-312 était bien toléré à tous les niveaux de dose, sans toxicité ni effets indésirables, soutenant ainsi une large fenêtre thérapeutique. L'entreprise reste sur la bonne voie pour le dépôt de la demande d'essai clinique (CTA) au 4e trimestre 2025, avec des interactions réglementaires productives qui appuient leur stratégie clinique.

e-therapeutics (OTCQX:ETXPF) hat bedeutende Fortschritte bei der Risikominderung seines Hauptkandidaten ETX-312, einer GalOmic siRNA-Therapie für metabolisch bedingte Steatohepatitis (MASH), bekannt gegeben. Das Unternehmen hat zwei wichtige Meilensteine erreicht: den erfolgreichen Abschluss von GLP-konformen Toxikologiestudien, die eine ausgezeichnete Verträglichkeit bei hohen Dosierungen zeigten, sowie die GMP-Herstellung der klinischen Prüfchargen.

Die Toxikologiestudien zeigten, dass ETX-312 in allen Dosierungsstufen gut vertragen wurde, ohne Toxizität oder unerwünschte Befunde, was ein breites therapeutisches Fenster unterstützt. Das Unternehmen bleibt im Zeitplan für die Einreichung des Clinical Trial Application (CTA) im vierten Quartal 2025 und profitiert von produktiven regulatorischen Interaktionen, die die klinische Strategie unterstützen.

Positive
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Negative
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ETX-312 well tolerated at exaggerated dose levels in GLP-compliant toxicology studies

GMP manufacturing of clinical trial batch successfully completed

On track for CTA submission in Q4 2025

LONDON, July 10, 2025 (GLOBE NEWSWIRE) -- e-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, today announced significant progress on its lead candidate, ETX-312, a GalOmic siRNA therapy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The Company has successfully de-risked the path to clinical entry for ETX-312 and remains on track to submit a clinical trial application (CTA) in Q4 2025.

ETX-312 was repeatedly administered at doses far exceeding anticipated clinical exposure in GLP-compliant toxicology and toxicokinetic studies. The candidate was well tolerated across all dose levels, with no toxicity or adverse findings observed. These non-clinical results support a broad therapeutic window for ETX-312 and strengthen confidence in the program and the GalOmic platform as it advances toward first-in-human trials.

In parallel, e-therapeutics has successfully completed GMP manufacturing of the clinical batch of ETX-312, supporting the Company’s operational readiness to progress to first-in-human dosing. Productive interactions with regulatory authorities have provided further support for our clinical strategy and plans.

“Recent results and progress on ETX-312 represent a pivotal step towards the clinical development of our first GalOmic therapeutic, designed to silence a novel target identified in-house� said Ali Mortazavi, CEO of e-therapeutics. “The tolerability profile of ETX-312 provides key de-risking for our program, supporting a Q4 2025 CTA filing. We look forward to advancing ETX-312 to first-in-human studies over the coming months and continuing to execute efficiently to offer a differentiated treatment option to MASH patients.�

About ETX-312
ETX-312 is a GalOmic GalNAc-conjugated small-interfering RNA (GalNAc-siRNA) therapeutic candidate in development as 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 dramatic reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation, and slowed fibrosis progression, both as monotherapy and in synergistic combination with approved and 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 predictivein silicosiRNA 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 pipelineof 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.

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FAQ

What are the key findings from ETX-312's toxicology studies by e-therapeutics (ETXPF)?

The GLP-compliant toxicology studies showed that ETX-312 was well tolerated across all dose levels, with no toxicity or adverse findings, even at doses far exceeding anticipated clinical exposure.

When will e-therapeutics submit the Clinical Trial Application (CTA) for ETX-312?

e-therapeutics plans to submit the Clinical Trial Application (CTA) for ETX-312 in Q4 2025.

What is ETX-312 being developed to treat?

ETX-312 is a GalOmic siRNA therapy being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

What manufacturing milestone has e-therapeutics achieved for ETX-312?

e-therapeutics has successfully completed GMP manufacturing of the clinical batch of ETX-312, supporting readiness for first-in-human dosing.

How does ETX-312 work as a treatment?

ETX-312 is a GalOmic siRNA therapy designed to silence a novel target identified in-house for treating MASH patients.
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