Tvardi Therapeutics reported positive Phase 1 results for its next-generation STAT3 inhibitor TTI-109, confirming its prodrug design and improved tolerability over predecessor TTI-101. The study showed TTI-109, a phosphate prodrug of TTI-101, was rapidly converted in the body within two hours, achieving plasma levels nearly identical to TTI-101 at equivalent doses, with sustained exposure above the STAT3 inhibitory threshold during 21 days of repeat dosing. Exploratory pharmacodynamic analyses demonstrated reductions of up to 60% in STAT3-driven immune cell populations, including Th17, T follicular helper, and B cell subsets. Diarrhoea events linked to TTI-109 were substantially shorter in duration compared to TTI-101, at 0.46 days versus 3.35 days, and episodes were transient, resolving without treatment interruption. CEO Imran Alibhai stated the results validate the prodrug strategy and support advancement into Phase 2 studies targeting STAT3-driven dermatologic and gastrointestinal diseases, contingent on additional funding.
Tvardi Therapeutics, Inc.Positive Phase 1 results for TTI-109 show improved tolerability and target engagement, validating prodrug strategy and supporting advancement to Phase 2.