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Tvardi Therapeutics’ TTI-109 Phase 1 Study Confirms Prodrug Design, Improved Tolerability and Pharmacodynamic Evidence of STAT3 Target Engagement

TVRD
  • Tvardi Therapeutics announced Phase 1 results for TTI-109, a phosphate prodrug of TTI-101 designed to improve delivery & tolerability while maintaining STAT3 inhibition.
  • TTI-109 demonstrated rapid conversion to TTI-101 within two hours & achieved exposure levels equivalent to the parent compound at molar-equivalent doses.
  • Pharmacokinetic data showed stable, dose-proportional exposure over 21 days with concentrations remaining above the STAT3 IC50 threshold.
  • Exploratory pharmacodynamic analysis revealed reductions of up to 60% in disease-relevant STAT3-driven immune cell populations, including Th17, T follicular helper (Tfh), & B cells.
  • TTI-109 showed improved tolerability compared to TTI-101, with diarrhea events being substantially shorter in duration (0.46 days vs. 3.35 days) & resolving without treatment interruption.
  • The Company plans to advance TTI-109 into dermatologic & gastrointestinal (GI) diseases, contingent upon Investigational New Drug (IND) clearance & additional funding.
  • TTI-109 targets the STAT3 node to address both cellular & humoral components of inflammation & proliferation in conditions where single-pathway biologics are currently used.
  • The study consisted of three parts: Part A (single ascending dose), Part B (bioequivalence crossover), & Part C (multiple ascending dose over 21 days).
  • Tvardi management will host an investor webcast on July 7, 2026, at 8:30 am ET to discuss these findings in detail.
  • The Company continues its Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma (NCT05440708) while preparing for potential Phase 2 trials of TTI-109.