Tvardi Therapeutics, Inc.
For the period ended Jul 7, 2026. Filed Jul 7, 2026.
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Jul 7, 2026 · Filed Jul 7, 2026
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Contents
EX-99.1 · Key findings include:
Key findings include:
| · | Confirmed prodrug conversion and exposure equivalence: Validating its prodrug design, TTI-109 rapidly converted to TTI-101 within two hours and produced nearly identical plasma levels at molar-equivalent doses. |
| · | Sustained target-level exposure: 21-day repeat dosing showed stable, dose-proportional pharmacokinetics, with TTI-101 concentrations above the STAT3 IC₅₀. |
| · | Evidence of target engagement: Pharmacodynamic data showed reductions of up to 60% across disease-relevant STAT3-driven immune cell populations including Th17 cells, Tfh and B cell subsets. |
| · | Improved tolerability vs. TTI-101: Compared with placebo, diarrhea events with TTI-109 were similar in duration, transient, and resolved without treatment interruption. Compared with TTI-101 at near-equivalent doses, diarrhea events with TTI-109 were substantially shorter in duration (0.46 vs. 3.35 days). |
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “These Phase 1 results validate our prodrug strategy on every objective we set out to test. TTI-109 matched TTI-101's exposure at molar-equivalent doses with substantially better tolerability and delivered a pharmacodynamic signal across disease-relevant immune cell populations that we would not typically expect to see in healthy volunteers. That combination of findings supports our development pathway into Phase 2.”
1 In a controlled system where proliferation is driven by WT STAT3, TTI-101 inhibits cell growth with an IC₅₀ of approximately 1.5µM. Kasembeli MM, Kaparos E, Bharadwaj U, et al. Aberrant function of pathogenic STAT3 mutant proteins is linked to altered stability of monomers and homodimers.Blood. 2023;141(12):1411-1424. doi:10.1182/blood.2021015330.
The study was conducted in three parts. Part A was a randomized, double-blind, placebo-controlled single ascending dose study of TTI-109 at four doses (n=8/cohort). Part B was a bioequivalence crossover comparing TTI-101 and TTI-109 in both sequences with a 48-hour washout (n=6/sequence). Part C was a randomized, double-blind, placebo-controlled multiple ascending dose study with 21 days of twice-daily dosing at four doses, plus a TTI-101 reference arm (n=8/cohort).
Primary objectives were to confirm rapid conversion of TTI-109 to TTI-101, demonstrate equivalent exposures at molar-equivalent doses, demonstrate dose-dependent increases in TTI-101 exposure and characterize safety and tolerability versus TTI-101 and placebo. Pharmacodynamic effects were an exploratory objective.
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