Tvardi Therapeutics Begins Phase 2 Trial for Novel IPF Treatment

Tvardi Therapeutics, First patient dosed, nintedanib, STAT3 inhibitors, idiopathic pulmonary fibrosis TTI-101

Tvardi Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing STAT3 inhibitors, has exciting news to share. They’ve initiated the dosing of the first patients in their groundbreaking REVERTIPF trial. This 12-week, randomized, double-blind study aims to assess the safety and clinical effectiveness of TTI-101 at three distinct dosage levels, either on its own or in combination with nintedanib (OFEV®). The objective is to compare these approaches against a placebo in individuals grappling with idiopathic pulmonary fibrosis (IPF).

“The REVERTIPF trial will expand our understanding of the impact of STAT3 inhibition beyond cancer into fibrotic diseases, which severely impair and burden hundreds of thousands of people globally. Interest in our IPF study continues to grow due to recently presented clinical data demonstrating TTI-101 was safe and effective in heavily pretreated cancer patients, published preclinical work highlighting TTI-101’s restorative effect in fibrosis, and the FDA’s Orphan Drug Designation for TTI-101 in IPF. This is the third of three Phase 2 trials Tvardi has initiated to address diseases driven by STAT3.”

– Imran Alibhai, PhD, CEO of Tvardi Therapeutics

IPF is a chronic and progressive lung ailment with an elusive origin, casting a shadow of uncertainty over its treatment. The prognosis for IPF patients is bleak, characterized by worsening respiratory symptoms, deteriorating lung function, and a loss of physical capabilities. While current approved therapies offer a glimmer of hope by slowing the disease’s progression, they fall short when it comes to reversing the clinical decline or restoring lung function. The race to find innovative ways to combat IPF is ongoing, but none have explored the potential of STAT3, a pivotal regulatory protein that plays a central role in the development of pulmonary fibrosis.

Enter TTI-101, an orally administered small molecule designed to be a direct inhibitor of STAT3. This novel approach holds promise in the quest to rewrite the narrative of IPF treatment.

For more information about the REVERTIPF trial currently enrolling at sites throughout the US, please visit (NCT05671835)

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