Curanex Pharmaceuticals announced that it has finished a 28‑day repeat‑dose toxicology study of its lead botanical drug candidate, Phyto‑N, in Sprague‑Dawley rats and dogs. The study evaluated oral tolerability across multiple dose levels and established the maximum feasible dose, which was six times the proposed clinical dose in dogs and four times in rats. All animals underwent comprehensive safety assessments—including hematology, coagulation, serum biochemistry, and histopathology of major organs—and no treatment‑related adverse findings of toxicological significance were observed at any dose level in either species.
The results reinforce Phyto‑N’s favorable safety profile, which is supported by more than 30 years of human use in China. The absence of toxicological findings at the maximum feasible dose provides a robust scientific foundation for the next phase of Curanex’s Good Laboratory Practice‑compliant toxicology program, a prerequisite for its planned Investigational New Drug (IND) application. The company expects to file the IND in the fourth quarter of 2026, moving the botanical drug closer to clinical trials and potential commercialization.
CEO Jun Liu said the completion of the toxicology study is an important and encouraging milestone that gives the company strong confidence in the safety foundation of Phyto‑N. Chief Operating Officer Liqin Xie noted that the dose‑range finding study was specifically designed to generate data needed to optimize the design of upcoming GLP toxicology studies, a critical step in the FDA‑required nonclinical package. Both executives emphasized that the study’s findings streamline the path forward and keep the company on schedule toward its target IND filing timeline.
The announcement follows a series of development milestones that have attracted investor interest, including the February 26 completion of a GMP‑compliant pilot‑scale batch of Phyto‑N. Together, these achievements demonstrate Curanex’s progress in advancing its lead candidate toward regulatory approval and underscore the company’s commitment to a regulatory‑aligned approach with the FDA.
The completion of the toxicology study positions Curanex to advance Phyto‑N into the next regulatory phase, with the IND filing slated for Q4 2026. Successful IND submission will enable the company to initiate Phase I clinical trials, bringing the botanical drug closer to potential approval for moderate to severe ulcerative colitis and opening a new therapeutic avenue for patients worldwide.
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