Tvardi Therapeutics, Inc., a clinical-stage biopharmaceutical company, engages in the development of novel, oral, and small molecule therapies targeting signal transducer and activator of transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet need in the United States. The company's lead product candidates include TTI-101, which is in Phase 1b/2 clinical development stage for fibrosis-driven diseases with an initial focus on idiopathic pulmonary fibrosis (IPF), and hepatocellular carcinoma (HCC); and TTI-109, an oral, small molecule STAT3 inhibitor which is in Phase-1 clinical trial stage. Tvardi Therapeutics, Inc. was founded in 2017 and is based in Sugar Land, Texas.
New Preclinical Data Further Support Potential for Tvardi’s STAT3 Inhibitors in Ulcerative Colitis (UC)
Tvardi published preclinical data in the International Journal of Molecular Sciences showing its oral STAT3 inhibitor TTI-101 prevented colon adenocarcinoma formation entirely (p≤0.05) in a chronic colitis-to-cancer mouse model.
TTI-101 accumulated in the colon at roughly 8-fold higher concentrations than in plasma and reached levels more than 20 times the STAT3 IC50, while normalizing disease-associated gene expression across immune, inflammatory and proliferative programs.
This is the fourth preclinical colitis model in which Tvardi's STAT3 inhibitors have shown activity, supporting advancement of next-generation prodrug TTI-109 into UC development following a completed Phase 1 healthy volunteer study.
Clinical trials of TTI-109 in GI diseases remain pending IND clearance and availability of additional funding, and the company continues a Phase 1b/2 trial of TTI-101 in hepatocellular carcinoma.