(RTTNews) - Curanex Pharmaceuticals Inc. (CURX), development-stage company focused on botanical drugs for inflammatory diseases, announced the completion of a Good Manufacturing Practice or GMP pilot-scale batch of its lead candidate, Phyto-N. The milestone will support the company's plan to submit an IND application for ulcerative colitis in the fourth quarter of 2026.
Operational Update
•The GMP-compliant pilot batch of Phyto-N will be used in GLP toxicology, pharmacokinetic, and other IND-enabling studies.
•Key Chemistry, Manufacturing and Controls activities completed include quality control methods for botanical raw materials, laboratory-scale process optimization, and scale-up production of GMP material.
•With pilot material available, Curanex is preparing to initiate formal GLP toxicology and pharmacokinetic studies.
Chief Executive Officer Jun Liu stated that completion of the GMP pilot batch represents a critical step in advancing Phyto-N toward regulatory submission. Chief Operating Officer Liqin Xie added that the company is positioned to move forward with GLP studies and remains on track for its targeted IND filing in late 2026.
Phyto-N is a botanical extract with anti-inflammatory properties under development for multiple indications, with ulcerative colitis as lead target. The condition affects approximately 5 million patients globally and represents a significant unmet medical need.
Non-GLP acute toxicity studies in rats and dogs have shown no treatment-related adverse findings, while metabolism studies demonstrated minimal interspecies variability.
CURX has traded between $0.28 and $9.18 over the past year. The stock is currently trading at $0.30, up 0.03%.
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