C-188-9

Tvardi’s previously announced merger with publicly traded Cara Therapeutics is on-track to close in 1H 2025 TTI-101 is currently being evaluated in a Phase 2 study in patients with idiopathic pulmonary fibrosis (REVERTIPF) and a Phase 2 study in patients with hepatocellular carcinoma (REVERTLIVER CANCER) March 19, 2025 -- Tvardi Therapeutics, Inc. (“Tvardi”), a clinical-stage biopharmaceutical company developing novel STAT3 inhibitors for fibrosis-driven diseases, announced today that results from the first-in-human Phase 1 study of TTI-101 in patients with advanced solid tumors have been published in the journal Clinical Cancer Research. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi Therapeutics, stated, “The positive results of this Phase 1 study speak to the potential broad clinical utility of our lead candidate, TTI-101, across a range of fibrosis-driven diseases in which STAT3-mediated proliferation is implicated. Perhaps most notable, in addition to its biological activity in advanced treatment-refractory hepatocellular carcinoma, was a pharmacodynamic reduction of TTI-101’s target, activated STAT3, within paired tumor biopsies. We believe these findings provide very strong rationale for our ongoing Phase 2 studies in IPF and liver cancer.” The publication, titled, “Phase 1 Trial of TTI-101, a First-in-Class Oral Inhibitor of STAT3, in Patients with Advanced Solid Tumors,” describes a Phase 1 study in which patients, who received a median of three prior systemic therapies, were treated with TTI-101 monotherapy orally twice daily (NCT03195699). By targeting both intrinsic tumorigenesis and extrinsic immune suppression, TTI-101 showed promising antitumor activity across tumor types, particularly in patients with hepatocellular carcinoma who were refractory to immune checkpoint inhibitors and anti-angiogenic agents. TTI-101 showed dose-linear pharmacokinetics and, at the recommended Phase 2 dose, the trough exposure levels were above the IC90 for STAT3-induced growth. No dose-limiting toxicities or treatment-related adverse events greater than grade 3 were observed. Pharmacodynamic analysis demonstrated TTI-101 decreased levels of phosphotyrosine (pY) STAT3 within paired tumor biopsies. Tvardi is a clinical stage, biopharmaceutical company focused on the discovery and development of oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). The content above comes from the network. if any infringement, please contact us to modify.