Tvardi Therapeutics Inc. (NASDAQ:TVRD) on Wednesday reported Phase 1 results for TTI-109, its next-generation STAT3 inhibitor. Following the announcement, the stock jumped nearly 50%.
The company said the investigational therapy demonstrated rapid conversion to its active form, dose-proportional pharmacokinetics, evidence of target engagement, and improved tolerability compared with TTI-101.
The company said the findings support plans to advance the candidate into dermatologic and gastrointestinal indications, subject to regulatory clearance and funding.
Phase 1 Study Meets Key Pharmacokinetic And Safety Goals
According to the company, TTI-109 is a phosphate prodrug of TTI-101 designed to improve drug delivery and tolerability while maintaining the same mechanism of action.
The Phase 1 study showed that TTI-109 converted to TTI-101 within two hours and achieved nearly identical plasma exposure at molar-equivalent doses, validating the prodrug approach.
After 21 days of repeat dosing, TTI-101 concentrations remained above the STAT3 IC₅₀, with pharmacokinetics remaining stable and dose proportional.
In an exploratory pharmacodynamic analysis, the study also showed reductions of up to 60% in STAT3-driven immune cell populations.
The company added that diarrhea events associated with TTI-109 were comparable to placebo in duration and resolved without treatment interruption.
Compared with near-equivalent doses of TTI-101, diarrhea episodes with TTI-109 were substantially shorter, averaging 0.46 days versus 3.35 days.
Company Targets Dermatology And Gastrointestinal Diseases
Tvardi said it plans to pursue dermatologic and gastrointestinal diseases where STAT3 serves as a central signaling node linking cytokines, growth factors, and immune pathways.
The company believes TTI-109’s mechanism may address both inflammatory and proliferative processes with a single oral therapy.
The company added that prior preclinical models and clinical studies of its STAT3 inhibitors demonstrated activity across inflammation, fibrosis, and immune regulation.
The TTI-109 healthy volunteer study further extended those findings by reducing STAT3-driven immune cell populations.
Tvardi noted that future clinical development will depend on clearance of an Investigational New Drug application and the availability of additional funding.
TVRD Stock Price Activity: Tvardi Therapeutics shares were up 49.75% at $3.010 at the time of publication on Tuesday, according to Benzinga Pro data.
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