PARAMUS, NJ, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”), announces it has selected a leading contract research organization (CRO) for SOTERIA, a phase 2, open-label, single-arm trial designed to evaluate the safety, tolerability, and clinical activity of Polaryx’s lead candidate, PLX-200, across four different LSDs. “Our selection of ...

Core Insights - Polaryx Therapeutics presented new data on PLX-200, a reformulated gemfibrozil, for treating Krabbe disease at the WORLDSymposium™ 2026, highlighting its potential as a disease-modifying therapy for lysosomal storage disorders (LSDs) [1][2][3] Company Overview - Polaryx Therapeutics is a clinical-stage biotechnology company focused on developing therapies for rare pediatric lysosomal storage disorders, aiming to address significant unmet medical needs [12] Scientific Findings - Preclinical studies showed that gemfibrozil, when administered orally in a mouse model of Krabbe disease, improved motor functions and increased lifespan by activating PPARβ and PPARα, leading to enhanced lysosome biogenesis and reduced neuroinflammation [2][5][6] - PLX-200 promotes the expression of anti-inflammatory genes and protects neuronal cells, contributing to its therapeutic potential in neurodegenerative diseases [6][10] Clinical Development - The SOTERIA trial, a Phase 2 open-label study, is set to evaluate the safety and efficacy of PLX-200 across multiple LSDs, with plans to initiate in the first half of 2026 following FDA approval [11][8] - The trial is designed to be flexible and resource-efficient, allowing for the collection of valuable data to inform future development pathways for PLX-200 [11][7] Market Context - Krabbe disease is caused by mutations in the GALC gene, leading to toxic metabolite accumulation and severe neurological decline, highlighting the critical need for effective treatments [9][10]