E-therapeutics presented preclinical data at the European Association for the Study of the Liver (EASL) Congress on ETX-312, a GalNAc-siRNA candidate for metabolic dysfunction-associated steatohepatitis (MASH). The data demonstrated significant improvements in NAFLD Activity Score (NAS) and slowed fibrosis progression in a preclinical mouse model, both as a monotherapy and in combination with other emerging therapies. The company plans to submit a regulatory submission by the end of 2025.
This positive preclinical data is important because it suggests ETX-312 could offer a differentiated approach to treating MASH, a condition with significant unmet medical need. The demonstrated efficacy in combination with existing therapies, such as GLP-1/GIP receptor agonists and FGF-21 analogues, could also broaden treatment options and potentially improve patient outcomes. This development furthers the potential for RNA interference (RNAi) therapeutics as a viable treatment modality for liver diseases.
ETX-312, leveraging the company’s GalOmic platform, achieved substantial reductions in NAS scores, up to 5 points, and demonstrated anti-fibrotic effects comparable to existing treatments. The success in both monotherapy and combination therapy settings highlights the potential versatility of this candidate. The company is currently conducting IND-enabling studies, with a regulatory submission anticipated by the end of 2025.
The promising preclinical results for ETX-312 reinforce the potential of e-therapeutics’ computational drug discovery platform. The advancement of this candidate towards clinical trials is a critical step towards potentially providing a new therapeutic option for patients with MASH. Further research and clinical development will be crucial to validate these findings and determine the efficacy and safety of ETX-312 in humans. The anticipated regulatory submission by the end of 2025 sets a clear timeline for the next stage of development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
