Tvardi Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in the development of STAT3 inhibitors, has reached a significant milestone by dosing the first patients in its REVERTIPF trial. The 12-week, randomized, double-blind study is designed to assess the safety and clinical efficacy of TTI-101. This novel STAT3 inhibitor is being tested at three distinct doses, both as a standalone treatment and in combination with nintedanib (OFEV), against a placebo in patients suffering from idiopathic pulmonary fibrosis (IPF).

IPF is a debilitating, chronic, and progressive lung disease with unknown causes and a grim prognosis. The condition often leads to declining lung function, worsening respiratory symptoms, and functional impairment. While there are approved treatments aimed at slowing down the disease’s progression, none have successfully reversed clinical decline or restored lung function. This trial puts the spotlight on STAT3, a key regulatory protein previously unexplored in IPF treatment research. TTI-101 is an orally-administered, small molecule that directly inhibits STAT3.

The CEO of Tvardi Therapeutics, Imran Alibhai, emphasized the significance of the REVERTIPF trial: “This study extends our comprehension of STAT3’s role beyond cancer, focusing now on fibrotic diseases that severely impact hundreds of thousands globally. The escalating interest in our IPF trial is fueled by encouraging clinical data showcasing TTI-101’s safety and effectiveness in cancer patients, preclinical work emphasizing its restorative effect on fibrosis, and the FDA’s Orphan Drug Designation for TTI-101 in IPF treatment.”

This milestone marks the third of Tvardi Therapeutics’ Phase 2 trials aimed at treating diseases driven by STAT3. The REVERTIPF trial, specifically focused on IPF, underscores Tvardi’s ongoing commitment to leveraging STAT3 inhibition as a promising pathway to tackle a range of life-altering conditions. It also adds another layer of hope for the hundreds of thousands affected by IPF, a disease notoriously difficult to treat, by offering a new potential avenue for effective treatment.

  Idiopathic pulmonary fibrosis, Imran Alibhai, nintedanib, TTI-101, Tvardi Therapeutics, USA