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Polaryx Therapeutics Selects Contract Research Organization for SOTERIA Phase 2 Basket Trial
PARAMUS, NJ, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel,
About this update from Polaryx Therapeutics, Inc.
[{"type":"text","content":"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 a CRO partner marks an important milestone for us as we continue to advance the clinical development of SOTERIA and move closer to the clinic,” said Lisa Bollinger, M.D., Chief Medical Officer of Polaryx Therapeutics, Inc. “Our new partner brings meaningful experience working with and managing LSD and rare pediatric trials, as well as deep-rooted relationships with the dedicated key opinion leaders and patient advocacy groups who work closely with patients and their families.” Polaryx continues to pursue its mission of addressing significant unmet medical needs in rare pediatric disorders by responsibly advancing programs that have the potential to deliver meaningful therapeutic options for patients and their families. The SOTERIA trial represents a flexible and resource‑efficient mechanism to continue the clinical development of PLX‑200 across multiple LSDs. Polaryx received a safe to proceed letter from the FDA in October 2025 and continues to actively work with its contract research organization (CRO) to initiate the trial in the first half of 2026. About PLX-200 Polaryx’s lead drug candidate, PLX-200, is an orally available compound comprised of gemfibrozil. Gemfibrozil is an FDA-approved lipid regulating agent in the fibrate family which has only been approved in a capsule form for adult patients with very high elevations of serum triglyceride levels to decrease serum triglycerides and very low-density lipoprotein cholesterol and increase high density lipoprotein cholesterol. The ability of gemfibrozil to cross the blood-brain barrier (“BBB”) has also been documented in third-party preclinical trials and safe use of gemfibrozil in adults has also been well-established over several decades of clinical investigation and commercial use, which we believe accelerates clinical development and reduces associated costs. We believ...