Polaryx Therapeutics, Inc. (PLYX) announced that it has selected a leading contract research organization to support SOTERIA, its Phase 2, open-label, single-arm basket trial evaluating PLX-200 in four lysosomal storage disorders (LSDs).
The trial is designed to assess the safety, tolerability, and clinical activity of PLX-200 in CLN2, CLN3, Karbbe disease, and Sandhoff disease, which together represent about one quarter of the LSD population.
Polaryx received a "safe to proceed" letter from the FDA in October 2025 and plans to initiate the study in the first half of 2026 across sites in the United States, Europe, and Asia.
PLX-200, an orally available compound comprised of gemfibrozil, has demonstrated the ability to cross the blood-brain barrier in preclinical studies. Its established safety profile in adults accelerates development and reduces costs, positioning it as a potential disease-modifying therapy for multiple rare pediatric LSDs.
The company emphasized that the CRO partner brings deep experience in rare pediatric trials and strong relationships with key opinion leaders and patient advocacy groups, which will help advance SOTERIA toward pivotal development.
Polaryx continues to pursue its mission of delivering meaningful therapeutic options for patients and families affected by catastrophic lysosomal storage disorders.
The shares of the company's common stock began trading on the Nasdaq Capital Market on February 2, 2026.
PLYX has traded between a low of $2.20 and a high of $48.91. The stock is currently trading at $3.64, up 50.80%.
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