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Tvardi Therapeutics Commences Phase 2 Clinical Trial for Idiopathic Pulmonary Fibrosis Using TTI-101, a Novel STAT3 Inhibitor First Patients Receive Doses

Friday, September 01, 2023

Tvardi Therapeutics, Inc., a privately held clinical-stage biopharmaceutical company with a focus on developing STAT3 inhibitors, has announced the initiation of patient dosing in its ongoing REVERTIPF trial. This 12-week study, conducted in a randomized, double-blind fashion, is designed to evaluate both the safety and clinical efficacy of TTI-101 at three distinct dosage levels. It will also examine the impact of TTI-101 when used alone or in combination with nintedanib (OFEV®) in comparison to a placebo. The trial is enrolling participants diagnosed with idiopathic pulmonary fibrosis (IPF).

IPF is a chronic and progressive lung disease with an unknown cause. It carries a grim prognosis, as most patients experience worsening respiratory symptoms, declining lung function, and reduced quality of life. Current approved treatments can slow the disease's progression but are unable to reverse clinical decline or restore lung function. Despite ongoing research efforts to discover new ways to treat IPF, none have specifically targeted STAT3, a crucial regulatory protein in the development of pulmonary fibrosis. TTI-101 is an orally administered small molecule that directly inhibits STAT3.

Dr. Imran Alibhai, the CEO of Tvardi Therapeutics, discussed the significance of the REVERTIPF trial, emphasizing its potential to expand our knowledge of how inhibiting STAT3 can benefit fibrotic diseases, which severely impact the lives of many people worldwide. Interest in the IPF study has grown due to recent clinical data demonstrating TTI-101's safety and effectiveness in heavily treated cancer patients, as well as published preclinical research highlighting TTI-101's potential to restore tissue in fibrosis. Additionally, the FDA has granted Orphan Drug Designation to TTI-101 for IPF. Dr. Alibhai noted that this marks the third Phase 2 trial initiated by Tvardi to address conditions driven by STAT3.

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