Business Wire·Oct 13, 2025, 7:30 AM ET

Tvardi Therapeutics Provides Update on Preliminary Data from Phase 2 REVERT Trial in Idiopathic Pulmonary Fibrosis

TVRD

Tvardi Therapeutics announced that its Phase 2 REVERT clinical trial of TTI-101 for idiopathic pulmonary fibrosis (IPF) did not meet its goals regarding safety & exploratory efficacy.
The randomized, double-blind study included 88 patients randomized to receive TTI-101 at 400mg or 800mg daily, or placebo, with 58% of participants also receiving nintedanib.
Discontinuation rates were significantly higher in TTI-101 treatment arms (56.7% & 62.1%) compared to the placebo arm (10.3%), primarily driven by gastrointestinal adverse events.
Preliminary efficacy analysis showed no statistically significant differences in Forced Vital Capacity (FVC) between treatment groups & placebo.
FVC change from baseline overlapped across all arms, with high variability & a lower-than-expected FVC decline observed in the placebo group.
CEO Imran Alibhai stated that aggregate data did not demonstrate a benefit of TTI-101 in this IPF study, citing the limited dataset & unexpected placebo performance.
The company remains on track to report preliminary data in the first half of 2026 from a healthy volunteer study on next-generation STAT3 inhibitor TTI-109 & a Phase 2 trial of TTI-101 for hepatocellular carcinoma.
TTI-109 is designed to enhance STAT3 targeting efficiency & improve tolerability compared to TTI-101.
As of June 30, 2025, Tvardi held $41.0 million in cash & equivalents, sufficient to fund operations through the fourth quarter of 2026.
Management will host a conference call on October 13, 2025, at 8:30 am ET to discuss the preliminary results.