Tvardi Therapeutics reports Phase 1 TTI-109 data showing bioequivalence to TTI-101, improved tolerability

Tvardi Therapeutics reported Phase 1 results showing TTI-109 converts rapidly to TTI-101, achieves equivalent exposure and shows improved GI tolerability with pharmacodynamic evidence of STAT3 target engagement.

Key Highlights:

• TTI-109 rapidly converted to active TTI-101 within two hours, producing near-identical plasma levels at molar-equivalent doses.
• 21-day repeat dosing showed stable, dose-proportional PK with TTI-101 concentrations above the STAT3 IC50, supporting sustained target-level exposure.
• Exploratory pharmacodynamics showed reductions up to 60% in STAT3-driven immune cell populations (Th17, Tfh and B cells).
• GI tolerability improved versus TTI-101: diarrhea with TTI-109 was transient, placebo-like and substantially shorter in duration (0.46 vs. 3.35 days).
• Company plans to advance TTI-109 into STAT3-driven dermatologic and GI indications, subject to IND clearance and additional funding.

Original SEC Filing:

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