Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 179

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 179
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TI-101.When comparing the drug-drug interactions between the two evaluated standard of care therapies when concurrently administered with TTI-101, optimal exposures were observed with nintedanib. Based on the findings of this healthy volunteer DDI clinical trial, we chose nintedanib as the standard of care in our ongoing Phase 2 clinical trial.Our Ongoing REVERT IPF Phase 2 Clinical Trial of TTI-101 in Patients suffering from IPFAs of May 2025, we have completed enrollment in a Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial of TTI-101 to evaluate its safety, tolerability, PK and preliminary efficacy in patients suffering from IPF. Approximately 75 patients are randomly assigned (1:1:1) to receive oral TTI-101 400 mg/ day, TTI-101 800 mg/day or placebo for 12 weeks as monotherapy or in addition to SoC, nintedanib. In addition to safety and PK endpoints, we plan to evaluate established Phase 3 efficacy endpoints including pulmonary function tests (“PFTs”), providing measurements for FVC and diffusing capacity of the lung for carbon monoxide (“DLCO”), six-minute walk test (“6MWT”), and imaging, including Quantitative Lung Fibrosis High Resolution CT (“HRCT”). Additionally, we will be evaluating validated biomarkers and patient reported outcomes (“PRO”s). The clinical trial is being conducted in 26 sites across the United States and is enrolling patients with mild and moderate IPF who have been on a stable dose of nintedanib or are not on anti-fibrotic therapy.

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<div align='center'>REVERTPhase 2 Clinical Trial of TTI-101 Evaluating Safety, PK, Biomarkers and Preliminary Efficacy including FVC in Patients suffering from IPF</div>

The dosing regimen of this clinical trial was informed by our learnings from our concurrently enrolling Phase 1b/2 clinical trial in HCC, where we explored escalating dosages of TTI-101 up to 1200 mg/day and determined 800 mg/day as the recommended monotherapy Phase 2 dose (“RP2D”). Based upon the HCC RP2D determination as well as other early data, we requested that the Safety Monitoring Committee of the Phase 2 clinical trial in IPF convene to consider discontinuation of enrollment to 1200 mg/day arm. In July 202