Tvardi Surges 48% on Phase 1 STAT3 Inhibitor Data

Tvardi Therapeutics released Phase 1 data for TTI-109, a next-generation STAT3 inhibitor. The study confirmed rapid conversion of the phosphate prodrug to the active compound TTI-101 and dose-proportional exposure above the STAT3 IC50. It also showed improved tolerability versus the earlier molecule TTI-101. An exploratory pharmacodynamic analysis found reductions of up to 60% in STAT3-driven immune cell populations, including Th17 and B cell subsets.

The stock surged 48% to $2.97 on volume of 49 million shares, with a range of $2.07 to $3.86.

TTI-109 targets STAT3, a downstream node where inflammatory and proliferative pathways converge. The company plans to pursue dermatologic and gastrointestinal indications that share STAT3-driven biology. TTI-101 previously reduced activated STAT3 levels and inflammatory cascades in preclinical models and in humans. The TTI-109 data extend that translational profile to healthy volunteers.

The Phase 1 program included three parts: a single-ascending-dose study, a bioequivalence crossover, and a multiple-ascending-dose study with a TTI-101 reference arm. Each cohort enrolled eight subjects.

The company said the results confirm STAT3's role as a central hub for inflammatory and proliferative signaling. Tvardi's ability to start new programs depends on IND clearance and additional funding. No timeline for those filings has been announced.