Tvardi Therapeutics Inc (TVRD) News & EventsTVRDTvardi Therapeutics Inc

Tvardi Therapeutics Publishes Preclinical Data on STAT3 Inhibitor

Tvardi Therapeutics announced the publication of preclinical data evaluating Tvardi's STAT3 inhibitor in the International Journal of Molecular Sciences. The publication provides additional evidence supporting further investigation of STAT3 inhibition as a potential therapeutic approach to treating inflammatory bowel diseases, including ulcerative colitis. Key highlights: In a preclinical chronic colitis model, Tvardi's oral small molecule accumulated in the colon at approximately 8-fold higher concentrations than in plasma, at pharmacologically relevant levels, and modulated STAT3-driven disease biology; Collective findings now span multiple preclinical models of UC, further supporting the scientific rationale for advancing TTI-109, Tvardi's next-generation STAT3 inhibitor, in UC

Tvardi Therapeutics Selects Ulcerative Colitis as Initial Indication for TTI-109

Tvardi Therapeutics announced that it has selected ulcerative colitis as the initial disease indication for its next generation STAT3 inhibitor, TTI-109. Tvardi plans to initiate a study of TTI-109 in patients with moderate-to-severe UC in 2027, subject to clearance of Investigational New Drug application and additional funding. The primary endpoint will be safety, and the secondary endpoint will be clinical remission at 12 weeks. Tvardi will host a Key Opinion Leader webinar featuring Randy Longman of Weill Cornell Medicine on Wednesday, August 19, at 11:00 a.m. ET.

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.