Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 175

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 175
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 all of whom received 1,200 mg/day of TTI-101 in addition to nintedanib or pirfenidone.

No severe adverse events (“SAEs”), were reported in this clinical trial. The most frequent treatment-emergent adverse events (“TEAEs”), were predominantly mild in severity and resolved on study with no change in therapy. One subject withdrew early due to a severe non-serious adverse event of pneumonia, which was deemed by the clinical trial investigator to be possibly related to TTI-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 IPF

As 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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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 en