Tvardi Therapeutics Reports Phase 1 Results for TTI-109 with Improved Tolerability

Tvardi Therapeutics announced results from its Phase 1 study of TTI-109, its next-generation STAT3 inhibitor. The study confirmed that TTI-109, designed as a prodrug of TTI-101, rapidly converted to the parent compound within two hours and demonstrated equivalent drug exposure with improved tolerability, including shorter-duration diarrhea events. Exploratory data also showed up to a 60% reduction in disease-relevant immune cell populations. Tvardi plans to advance the candidate into Phase 2 development for dermatologic and gastrointestinal diseases, pending regulatory clearance and funding. "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," said Imran Alibhai, CEO of Tvardi.