Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 44

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 44
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 Report.

Recent Developments

Unblinded Data from Phase 2 Clinical Trial

We reported preliminary data from our REVERT IPF
Phase 2 clinical trial of TTI-101 in IPF in October 2025. After reviewing the preliminary safety data and exploratory efficacy results,
including changes in forced vital capacity (FVC), we concluded that the study did not meet its goals. We are conducting additional analyses
to further understand these results and inform next steps.

​

The trial was a Phase 2, multicenter, randomized,
double-blind, placebo-controlled clinical trial of TTI-101 to evaluate safety, tolerability and PK in patients suffering from IPF. In
addition to safety and PK endpoints, we evaluated 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 evaluated validated biomarkers and patient reported outcomes (PROs). The clinical
trial was conducted in 26 sites across the United States and enrolled patients with mild and moderate IPF who had been on a stable dose
of nintedanib or were not on anti-fibrotic therapy.

​

Overall, 88 patients were randomized to TTI-101
400mg per day (n=30), 800mg per day (n=29) or placebo (n=29), and stratified by nintedanib use, with 58% of patients receiving concomitant
therapy. Preliminary data demonstrated patients’ baseline characteristics were similar across treatment arms, with the exception
of percent predicted FVC, which was lower in the placebo-treated patients (70.1%) compared to the TTI-101-treated arms (74.1% and
81.1%, respectively).

​

Discontinuation rates across treatment arms were
imbalanced, with lower discontinuation rates observed in the placebo group (10.3%) compared to treated arms (400mg and 800mg; 56.7% vs
62.1%, respectively). Discontinuation rates among the TTI-101 population were primarily driven by gastrointestinal adverse events, with
higher rates of events and discontinuations among patients on concurrent nintedanib. Deaths across treatment arms were balanced, with
one event observed in each arm.

​

The number of efficacy eval