Core Insights - e-therapeutics plc has made significant progress with its lead candidate ETX-312, a GalOmic siRNA therapy for metabolic dysfunction-associated steatohepatitis (MASH), and is on track to submit a clinical trial application (CTA) in Q4 2025 [1][4] Group 1: Clinical Development Progress - ETX-312 was well tolerated in GLP-compliant toxicology studies at doses far exceeding anticipated clinical exposure, indicating a broad therapeutic window [2][4] - The company has successfully completed GMP manufacturing of the clinical batch of ETX-312, demonstrating operational readiness for first-in-human dosing [3][4] - The tolerability profile of ETX-312 supports the clinical strategy and plans for a CTA filing in Q4 2025 [4] Group 2: Product Details - ETX-312 is a GalNAc-conjugated small-interfering RNA therapeutic candidate aimed at treating MASH, with potential for quarterly subcutaneous dosing [5] - Preclinical studies have shown that ETX-312 leads to significant reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation, and slowed fibrosis progression [5] Group 3: Company Overview - e-therapeutics plc combines computational power and RNAi to develop innovative medicines, utilizing its proprietary GalOmic platform for effective gene silencing [6][7] - The company has established a robust position in applying computational approaches to biology, validated through successful collaborations with biopharma companies [6][7]